Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00121641

Enrollment

1035

Registered

2005-07-21

Start date

2005-07-31

Completion date

2010-02-28

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

Detailed description

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) \> 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Interventions

DRUGPlacebo matching Saxagliptin

Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)

DRUGSaxagliptin

Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\])

DRUGMetformin

Tablets, Oral, 500 mg, daily (42 months LT)

DRUGPlacebo matching Metformin

Tablets, Oral, 0 mg, daily (42 months LT)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 77 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes mellitus * Drug naive * Hemoglobin (Hb) A1c \>= 7.0% and \<= 10.0% (\>10% and \<= 12% for open label arm) * Fasting C-peptide \>= 1 ng/mL * Body mass index \<= 40 kg/m2

Exclusion criteria

* Symptomatic poorly controlled diabetes * Recent cardiac or cerebrovascular event * Serum creatinine \>= 1.5 mg/dL for males and \>= 1.4 mg/dL for Women of Child Bearing Potential

Design outcomes

Primary

Measure	Time frame	Description
Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Baseline, Week 24	To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
A1C Changes From Baseline at Week 24 - Open Label Cohort	Baseline, Week 24	To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.

Secondary

Measure	Time frame
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Baseline, Week 24
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort	Baseline, Week 24
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Baseline, Week 24
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort	Baseline, Week 24
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort	Week 24
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24	Week 24

Other

Measure	Time frame	Description
Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Changes From Baseline in Heart Rate During the ST + LT Period	Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort	Baseline	This cohort represents a different population (screening A1C \> 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.
Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort	AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.
Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks.	A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: \<0.9 x Pre-Rx & \<=130mEq/L / high: \>1.1 x Pre-Rx & \>=150mEq/L; potassium, serum low: \<=0.8 x Pre-Rx & \>=6.0mEq/L / high: 1.2 x Pre-Rx & \>=6.0mEq/L; LLN=lower limit of normal.
All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period	AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.	Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.
Confirmed Hypoglycemia During ST + LT Treatment Period	AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.	'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose \<= 50 mg/dL and associated symptoms
All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort	AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.	Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.
Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort	AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.	'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose \<= 50 mg/dL and associated symptoms
Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Baseline, Weeks 12, 24, 76, 102, 154, 206	The normality/abnormality of the ECG tracing was determined by the investigator.
Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167	—
Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167	—
Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167	—
Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Baseline, Weeks 12, 24, 76, 102, 154, 206	The normality/abnormality of the ECG tracing was determined by the investigator.
Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Baseline	This cohort represents a different population (screening A1C \> 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.
Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort	Baseline	This cohort represents a different population (screening A1C \> 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.
Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort	Baseline	This cohort represents a different population (screening A1C \> 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.
Overall Summary of Adverse Events During ST+LT Treatment Period	AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.
Marked Laboratory Abnormalities - During ST + LT Treatment Period	Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.	A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: \<0.9 x Pre-Rx & \<=130mEq/L / high: \>1.1 x Pre-Rx & \>=150mEq/L; potassium, serum low: \<=0.8 x Pre-Rx & \>=6.0mEq/L / high: 1.2 x Pre-Rx & \>=6.0mEq/L; LLN=lower limit of normal.
Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—
Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206	—

Countries

Australia, Canada, Mexico, Puerto Rico, Taiwan, United States

Participant flow

Pre-assignment details

1035 subjects were enrolled; 422 entered the 2-week dietary/exercise placebo lead-in. 21 did not enter double-blind treatment period (19 discontinued, 2 randomized but did not receive study drug). 68 with screening hemoglobin A1c (A1C) \>10.0% and ≤12.0% entered directly in the open-label cohort; 66 received at least 1 dose of saxagliptin 10mg.

Participants by arm

Arm	Count
Saxagliptin 2.5 mg Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).	102
Saxagliptin 5 mg Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).	106
Saxagliptin 10 mg Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).	98
Placebo Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)	95
Total	401

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004
24-week Short-term Treatment Period	Adverse Event	3	3	4	0	2
24-week Short-term Treatment Period	Lack of Efficacy	15	21	14	25	30
24-week Short-term Treatment Period	Lost to Follow-up	0	2	3	4	4
24-week Short-term Treatment Period	Other Reason	1	0	0	0	0
24-week Short-term Treatment Period	Poor / Non-compliance	0	0	3	1	1
24-week Short-term Treatment Period	Subject No Longer Meets Study Criteria	1	1	0	0	1
24-week Short-term Treatment Period	Subject Withdrew Consent	9	11	5	10	3
48-month Short Term + Long Term Period	Administrative Reason by Sponsor	0	2	1	0	1
48-month Short Term + Long Term Period	Adverse Event	9	10	10	5	5
48-month Short Term + Long Term Period	Death	0	0	0	1	0
48-month Short Term + Long Term Period	Lack of Efficacy	26	27	21	26	25
48-month Short Term + Long Term Period	Lost to Follow-up	9	7	12	11	12
48-month Short Term + Long Term Period	Missing	0	0	1	0	0
48-month Short Term + Long Term Period	Other Reason	5	3	2	0	1
48-month Short Term + Long Term Period	Poor / Non-compliance	4	1	4	2	2
48-month Short Term + Long Term Period	Pregnancy	0	1	0	1	0
48-month Short Term + Long Term Period	Subject No Longer Meets Study Criteria	1	3	2	1	2
48-month Short Term + Long Term Period	Subject Withdrew Consent	25	28	17	24	10

Baseline characteristics

Characteristic	Saxagliptin 2.5 mg	Total	Placebo	Saxagliptin 10 mg	Saxagliptin 5 mg
Age Categorization, Female Only =< 50 years	17 Participants	82 Participants	19 Participants	22 Participants	24 Participants
Age Categorization, Female Only > 50 years	27 Participants	115 Participants	29 Participants	31 Participants	28 Participants
Age, Continuous	53.27 years STANDARD_DEVIATION 10.06	53.46 years STANDARD_DEVIATION 11.29	53.91 years STANDARD_DEVIATION 12.32	52.73 years STANDARD_DEVIATION 11.27	53.91 years STANDARD_DEVIATION 11.57
Age, Customized <65 years	91 participants	338 participants	77 participants	84 participants	86 participants
Age, Customized >= 65 years	11 participants	63 participants	18 participants	14 participants	20 participants
Age, Customized >=75 years	2 participants	6 participants	2 participants	1 participants	1 participants
Body Mass Index	31.90 kg/m^2 STANDARD_DEVIATION 4.82	31.73 kg/m^2 STANDARD_DEVIATION 4.6	30.93 kg/m^2 STANDARD_DEVIATION 4.26	31.71 kg/m^2 STANDARD_DEVIATION 4.71	32.30 kg/m^2 STANDARD_DEVIATION 4.53
Body Mass Index Categorization < 30	36 Participants	153 Participants	42 Participants	35 Participants	40 Participants
Body Mass Index Categorization >= 30	66 Participants	248 Participants	53 Participants	63 Participants	66 Participants
Race/Ethnicity, Customized Asian	5 participants	18 participants	3 participants	6 participants	4 participants
Race/Ethnicity, Customized Black/African American	5 participants	22 participants	6 participants	6 participants	5 participants
Race/Ethnicity, Customized Hispanic / Latino	16 Partcipants	59 Partcipants	15 Partcipants	14 Partcipants	14 Partcipants
Race/Ethnicity, Customized Not Hispanic / Latino	45 Partcipants	174 Partcipants	38 Partcipants	42 Partcipants	49 Partcipants
Race/Ethnicity, Customized Not Reported	41 Partcipants	168 Partcipants	42 Partcipants	0 participants	43 Partcipants
Race/Ethnicity, Customized Other	3 participants	20 participants	7 participants	6 participants	4 participants
Race/Ethnicity, Customized White	89 participants	341 participants	79 participants	80 participants	93 participants
Sex: Female, Male Female	44 Participants	197 Participants	48 Participants	53 Participants	52 Participants
Sex: Female, Male Male	58 Participants	204 Participants	47 Participants	45 Participants	54 Participants
Weight	92.10 kg STANDARD_DEVIATION 18.39	89.84 kg STANDARD_DEVIATION 17.96	86.56 kg STANDARD_DEVIATION 16.9	89.30 kg STANDARD_DEVIATION 17.67	91.09 kg STANDARD_DEVIATION 18.53

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	39 / 66	63 / 95	69 / 98	72 / 102	77 / 106
serious Total, serious adverse events	6 / 66	11 / 95	9 / 98	11 / 102	18 / 106

Outcome results

Primary

A1C Changes From Baseline at Week 24 - Open Label Cohort

To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.

Time frame: Baseline, Week 24

Population: Open-label participants with both a baseline and a post-baseline (up to Week 24)

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	A1C Changes From Baseline at Week 24 - Open Label Cohort	Baseline Mean	10.70 Percentage of glycosylated hemoglobins	Standard Error 0.1
Saxagliptin 2.5 mg	A1C Changes From Baseline at Week 24 - Open Label Cohort	Mean Change from Baseline	-1.87 Percentage of glycosylated hemoglobins	Standard Error 0.18

Primary

Hemoglobin A1c (A1C) Changes From Baseline at Week 24

Time frame: Baseline, Week 24

Population: Randomized participants with both a baseline and post-baseline value (up to Week 24).

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Baseline Mean	7.91 Percentage of glycosylated hemoglobins	Standard Error 0.09
Saxagliptin 2.5 mg	Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Adjusted Mean Change from Baseline	-0.43 Percentage of glycosylated hemoglobins	Standard Error 0.1
Saxagliptin 5 mg	Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Adjusted Mean Change from Baseline	-0.46 Percentage of glycosylated hemoglobins	Standard Error 0.1
Saxagliptin 5 mg	Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Baseline Mean	7.98 Percentage of glycosylated hemoglobins	Standard Error 0.11
Saxagliptin 10 mg	Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Baseline Mean	7.85 Percentage of glycosylated hemoglobins	Standard Error 0.09
Saxagliptin 10 mg	Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Adjusted Mean Change from Baseline	-0.54 Percentage of glycosylated hemoglobins	Standard Error 0.1
Placebo	Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Baseline Mean	7.88 Percentage of glycosylated hemoglobins	Standard Error 0.1
Placebo	Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Adjusted Mean Change from Baseline	0.19 Percentage of glycosylated hemoglobins	Standard Error 0.1

p-value: <0.000195% CI: [-0.9, -0.33]ANCOVA

p-value: <0.000195% CI: [-0.93, -0.36]ANCOVA

p-value: <0.000195% CI: [-1.02, -0.44]ANCOVA

Secondary

Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)

Time frame: Baseline, Week 24

Population: Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Baseline	177.72 mg/dL	Standard Error 4.12
Saxagliptin 2.5 mg	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Adjusted Change from Baseline	-14.53 mg/dL	Standard Error 3.82
Saxagliptin 5 mg	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Adjusted Change from Baseline	-8.67 mg/dL	Standard Error 3.74
Saxagliptin 5 mg	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Baseline	171.31 mg/dL	Standard Error 4.09
Saxagliptin 10 mg	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Baseline	176.51 mg/dL	Standard Error 4.43
Saxagliptin 10 mg	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Adjusted Change from Baseline	-16.75 mg/dL	Standard Error 3.89
Placebo	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Baseline	171.85 mg/dL	Standard Error 4.8
Placebo	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Adjusted Change from Baseline	6.06 mg/dL	Standard Error 4

p-value: 0.000295% CI: [-31.47, -9.72]ANCOVA

p-value: 0.007495% CI: [-25.5, -3.97]ANCOVA

p-value: <0.000195% CI: [-33.79, -11.84]ANCOVA

Secondary

Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort

Time frame: Baseline, Week 24

Population: Open Label Subjects with Measurement at Timepoint; Last Observation Carried Forward (LOCF)

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort	Baseline	241.08 mg/dL	Standard Error 6.19
Saxagliptin 2.5 mg	Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort	Change from Baseline	-33.42 mg/dL	Standard Error 5.37

Secondary

Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)

Time frame: Baseline, Week 24

Population: Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Baseline	45030 mg*min/dL	Standard Error 1368.1
Saxagliptin 2.5 mg	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Adjusted Change from Baseline	-6868 mg*min/dL	Standard Error 1167.7
Saxagliptin 5 mg	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Adjusted Change from Baseline	-6896 mg*min/dL	Standard Error 1130.2
Saxagliptin 5 mg	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Baseline	45691 mg*min/dL	Standard Error 1209.8
Saxagliptin 10 mg	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Baseline	44614 mg*min/dL	Standard Error 1394
Saxagliptin 10 mg	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Adjusted Change from Baseline	-8084 mg*min/dL	Standard Error 1176.2
Placebo	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Baseline	46030 mg*min/dL	Standard Error 1397.8
Placebo	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Adjusted Change from Baseline	-646.6 mg*min/dL	Standard Error 1236.9

p-value: 0.000395% CI: [-9570, -2872]ANCOVA

p-value: 0.000295% CI: [-9546, -2952]ANCOVA

p-value: <0.000195% CI: [-10798, -4076]ANCOVA

Secondary

Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort

Time frame: Baseline, Week 24

Population: Open Label participants with measure at given time points, Last Observation Carried Forward (LOCF).

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort	Baseline	60687 mg*min/dL	Standard Error 2312.4
Saxagliptin 2.5 mg	Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort	Change from Baseline	-11078 mg*min/dL	Standard Error 2132.8

Secondary

Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24

Time frame: Week 24

Population: Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)

Arm	Measure	Value (NUMBER)
Saxagliptin 2.5 mg	Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24	35.0 percentage of participants
Saxagliptin 5 mg	Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24	37.9 percentage of participants
Saxagliptin 10 mg	Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24	41.1 percentage of participants
Placebo	Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24	23.9 percentage of participants

p-value: 0.114195% CI: [-3.1, 24.9]Fisher Exact

p-value: 0.044395% CI: [-0.1, 27.6]Fisher Exact

p-value: 0.013395% CI: [2.8, 31]Fisher Exact

Secondary

Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort

Time frame: Week 24

Population: Open Label Participants with measurement at time point, Last Observation Carried Forward (LOCF)

Arm	Measure	Value (NUMBER)
Saxagliptin 2.5 mg	Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort	14.1 percentage of participants

Other Pre-specified

All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period

Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.

Time frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.

Population: Treated participants

Arm	Measure	Value (NUMBER)
Saxagliptin 2.5 mg	All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period	9 participants
Saxagliptin 5 mg	All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period	11 participants
Saxagliptin 10 mg	All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period	10 participants
Placebo	All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period	9 participants

Other Pre-specified

All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort

Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.

Time frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.

Population: Treated participants

Arm	Measure	Value (NUMBER)
Saxagliptin 2.5 mg	All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort	2 participants

Other Pre-specified

Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.01 x 10^3 c/µL	Standard Error 0.003
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.01 x 10^3 c/µL	Standard Error 0.01
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.02 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	0.00 x 10^3 c/µL	Standard Error 0.003
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.02 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.02 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.02 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.02 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.02 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.01 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.00 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.02 x 10^3 c/µL	Standard Error 0.009
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.03 x 10^3 c/µL	Standard Error 0.008
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.01 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.02 x 10^3 c/µL	Standard Error 0.008
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	0.00 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.03 x 10^3 c/µL	Standard Error 0.008
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.01 x 10^3 c/µL	Standard Error 0.009
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.01 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.00 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.03 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.02 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.01 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	-0.00 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.00 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.01 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.00 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.02 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.01 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.02 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.00 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.02 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.02 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.02 x 10^3 c/µL	Standard Error 0.01
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.02 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.03 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.01 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.01 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.01 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.01 x 10^3 c/µL	Standard Error 0.008
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.02 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.02 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.01 x 10^3 c/µL	Standard Error 0.003
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.00 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.01 x 10^3 c/µL	Standard Error 0.003
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.00 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.01 x 10^3 c/µL	Standard Error 0.004
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.00 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.01 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	-0.01 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.00 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.01 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.02 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.02 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.02 x 10^3 c/µL	Standard Error 0.005
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.01 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.01 x 10^3 c/µL	Standard Error 0.006
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.01 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.02 x 10^3 c/µL	Standard Error 0.009
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.01 x 10^3 c/µL	Standard Error 0.008
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.00 x 10^3 c/µL	Standard Error 0.007
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.01 x 10^3 c/µL	Standard Error 0.008
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.01 x 10^3 c/µL	Standard Error 0.01
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.01 x 10^3 c/µL	Standard Error 0.006
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.01 x 10^3 c/µL	Standard Error 0.006
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.00 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.03 x 10^3 c/µL	Standard Error 0.008
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	-0.00 x 10^3 c/µL	Standard Error 0.006
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.00 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.01 x 10^3 c/µL	Standard Error 0.009
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.02 x 10^3 c/µL	Standard Error 0.009
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.01 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.01 x 10^3 c/µL	Standard Error 0.006
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.02 x 10^3 c/µL	Standard Error 0.008
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.01 x 10^3 c/µL	Standard Error 0.01
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	-0.00 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.00 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	0.00 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.02 x 10^3 c/µL	Standard Error 0.008
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	-0.01 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.01 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.02 x 10^3 c/µL	Standard Error 0.004
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.02 x 10^3 c/µL	Standard Error 0.006
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.01 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.02 x 10^3 c/µL	Standard Error 0.004
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.02 x 10^3 c/µL	Standard Error 0.009
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.02 x 10^3 c/µL	Standard Error 0.007
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.02 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.00 x 10^3 c/µL	Standard Error 0.007
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.01 x 10^3 c/µL	Standard Error 0.005
Placebo	Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.03 x 10^3 c/µL	Standard Error 0.008

Other Pre-specified

Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.18 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	-0.01 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.03 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	0.00 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	-0.00 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	-0.00 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.03 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	-0.03 x 10^3 c/µL	Standard Error 0.01
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.02 x 10^3 c/µL	Standard Error 0.025
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	-0.03 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	-0.01 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.02 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.00 x 10^3 c/µL	Standard Error 0.024
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.00 x 10^3 c/µL	Standard Error 0.026
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	-0.01 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.02 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	-0.02 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.02 x 10^3 c/µL	Standard Error 0.01
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.02 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.00 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.02 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	-0.00 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.01 x 10^3 c/µL	Standard Error 0.009
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	-0.01 x 10^3 c/µL	Standard Error 0.02
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.02 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	-0.03 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.01 x 10^3 c/µL	Standard Error 0.008
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	-0.02 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	-0.01 x 10^3 c/µL	Standard Error 0.024
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	-0.01 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	-0.01 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.07 x 10^3 c/µL	Standard Error 0.051
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	-0.00 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.01 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.03 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	-0.03 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.02 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.00 x 10^3 c/µL	Standard Error 0.025
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.01 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.01 x 10^3 c/µL	Standard Error 0.027
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.01 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.04 x 10^3 c/µL	Standard Error 0.022
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	-0.00 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.01 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.02 x 10^3 c/µL	Standard Error 0.018
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	-0.02 x 10^3 c/µL	Standard Error 0.025
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	0.01 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.01 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	-0.00 x 10^3 c/µL	Standard Error 0.028
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	-0.02 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.20 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.02 x 10^3 c/µL	Standard Error 0.046
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	-0.03 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.02 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.03 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	-0.02 x 10^3 c/µL	Standard Error 0.02
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.02 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.20 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.02 x 10^3 c/µL	Standard Error 0.009
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.01 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.02 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.02 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	-0.02 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.01 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	-0.01 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.03 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.03 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.04 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	-0.04 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.03 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	-0.02 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	-0.04 x 10^3 c/µL	Standard Error 0.012
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.02 x 10^3 c/µL	Standard Error 0.011
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	-0.00 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	-0.02 x 10^3 c/µL	Standard Error 0.013
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.02 x 10^3 c/µL	Standard Error 0.016
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	-0.01 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	-0.03 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	-0.00 x 10^3 c/µL	Standard Error 0.016
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	-0.01 x 10^3 c/µL	Standard Error 0.018
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.01 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.00 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.00 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.03 x 10^3 c/µL	Standard Error 0.016
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	-0.03 x 10^3 c/µL	Standard Error 0.016
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.04 x 10^3 c/µL	Standard Error 0.016
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.02 x 10^3 c/µL	Standard Error 0.012
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	-0.01 x 10^3 c/µL	Standard Error 0.025
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	-0.02 x 10^3 c/µL	Standard Error 0.016
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.03 x 10^3 c/µL	Standard Error 0.016
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.06 x 10^3 c/µL	Standard Error 0.026
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.01 x 10^3 c/µL	Standard Error 0.02
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.00 x 10^3 c/µL	Standard Error 0.02
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.00 x 10^3 c/µL	Standard Error 0.018
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.05 x 10^3 c/µL	Standard Error 0.032
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.03 x 10^3 c/µL	Standard Error 0.021
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	-0.01 x 10^3 c/µL	Standard Error 0.017
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.02 x 10^3 c/µL	Standard Error 0.013
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.02 x 10^3 c/µL	Standard Error 0.013
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.06 x 10^3 c/µL	Standard Error 0.039
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.01 x 10^3 c/µL	Standard Error 0.015
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.01 x 10^3 c/µL	Standard Error 0.015
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.20 x 10^3 c/µL	Standard Error 0.016
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	-0.02 x 10^3 c/µL	Standard Error 0.02
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.03 x 10^3 c/µL	Standard Error 0.02
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	-0.02 x 10^3 c/µL	Standard Error 0.013
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.07 x 10^3 c/µL	Standard Error 0.04
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	-0.01 x 10^3 c/µL	Standard Error 0.018
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.01 x 10^3 c/µL	Standard Error 0.018
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	-0.02 x 10^3 c/µL	Standard Error 0.02
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.02 x 10^3 c/µL	Standard Error 0.014
Placebo	Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	-0.00 x 10^3 c/µL	Standard Error 0.023

Other Pre-specified

Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	2.16 x 10^3 c/µL	Standard Error 0.062
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	-0.06 x 10^3 c/µL	Standard Error 0.094
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.06 x 10^3 c/µL	Standard Error 0.071
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.07 x 10^3 c/µL	Standard Error 0.049
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.15 x 10^3 c/µL	Standard Error 0.08
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	-0.06 x 10^3 c/µL	Standard Error 0.077
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.10 x 10^3 c/µL	Standard Error 0.086
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.05 x 10^3 c/µL	Standard Error 0.067
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 48, 51, 40)	-0.17 x 10^3 c/µL	Standard Error 0.081
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.12 x 10^3 c/µL	Standard Error 0.087
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.07 x 10^3 c/µL	Standard Error 0.069
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.15 x 10^3 c/µL	Standard Error 0.107
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.06 x 10^3 c/µL	Standard Error 0.049
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	-0.17 x 10^3 c/µL	Standard Error 0.126
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.20 x 10^3 c/µL	Standard Error 0.071
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.03 x 10^3 c/µL	Standard Error 0.056
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	-0.23 x 10^3 c/µL	Standard Error 0.096
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.03 x 10^3 c/µL	Standard Error 0.065
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.11 x 10^3 c/µL	Standard Error 0.079
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	-0.23 x 10^3 c/µL	Standard Error 0.096
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.08 x 10^3 c/µL	Standard Error 0.065
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.16 x 10^3 c/µL	Standard Error 0.069
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.04 x 10^3 c/µL	Standard Error 0.049
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	-0.13 x 10^3 c/µL	Standard Error 0.089
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.00 x 10^3 c/µL	Standard Error 0.068
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.08 x 10^3 c/µL	Standard Error 0.066
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.04 x 10^3 c/µL	Standard Error 0.052
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.12 x 10^3 c/µL	Standard Error 0.106
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	-0.09 x 10^3 c/µL	Standard Error 0.151
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.02 x 10^3 c/µL	Standard Error 0.064
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.08 x 10^3 c/µL	Standard Error 0.085
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.00 x 10^3 c/µL	Standard Error 0.103
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	-0.03 x 10^3 c/µL	Standard Error 0.083
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.09 x 10^3 c/µL	Standard Error 0.069
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.07 x 10^3 c/µL	Standard Error 0.071
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.13 x 10^3 c/µL	Standard Error 0.083
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.01 x 10^3 c/µL	Standard Error 0.057
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	-0.10 x 10^3 c/µL	Standard Error 0.063
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.11 x 10^3 c/µL	Standard Error 0.049
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 48, 51, 40)	-0.07 x 10^3 c/µL	Standard Error 0.086
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.12 x 10^3 c/µL	Standard Error 0.046
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.09 x 10^3 c/µL	Standard Error 0.082
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.04 x 10^3 c/µL	Standard Error 0.128
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.09 x 10^3 c/µL	Standard Error 0.057
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.13 x 10^3 c/µL	Standard Error 0.064
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.02 x 10^3 c/µL	Standard Error 0.08
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.10 x 10^3 c/µL	Standard Error 0.045
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.22 x 10^3 c/µL	Standard Error 0.13
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	-0.14 x 10^3 c/µL	Standard Error 0.105
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.02 x 10^3 c/µL	Standard Error 0.055
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	2.21 x 10^3 c/µL	Standard Error 0.071
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.00 x 10^3 c/µL	Standard Error 0.105
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	-0.00 x 10^3 c/µL	Standard Error 0.06
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.12 x 10^3 c/µL	Standard Error 0.044
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.02 x 10^3 c/µL	Standard Error 0.064
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	-0.13 x 10^3 c/µL	Standard Error 0.118
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.18 x 10^3 c/µL	Standard Error 0.054
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	2.14 x 10^3 c/µL	Standard Error 0.063
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.11 x 10^3 c/µL	Standard Error 0.046
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.18 x 10^3 c/µL	Standard Error 0.046
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.23 x 10^3 c/µL	Standard Error 0.047
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.20 x 10^3 c/µL	Standard Error 0.048
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	-0.10 x 10^3 c/µL	Standard Error 0.053
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.16 x 10^3 c/µL	Standard Error 0.052
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	-0.01 x 10^3 c/µL	Standard Error 0.052
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.11 x 10^3 c/µL	Standard Error 0.049
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.01 x 10^3 c/µL	Standard Error 0.064
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.10 x 10^3 c/µL	Standard Error 0.058
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	-0.07 x 10^3 c/µL	Standard Error 0.06
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.13 x 10^3 c/µL	Standard Error 0.054
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	-0.09 x 10^3 c/µL	Standard Error 0.063
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	-0.17 x 10^3 c/µL	Standard Error 0.056
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.25 x 10^3 c/µL	Standard Error 0.051
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	-0.19 x 10^3 c/µL	Standard Error 0.07
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.19 x 10^3 c/µL	Standard Error 0.054
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 48, 51, 40)	-0.23 x 10^3 c/µL	Standard Error 0.056
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.21 x 10^3 c/µL	Standard Error 0.068
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.16 x 10^3 c/µL	Standard Error 0.068
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	-0.10 x 10^3 c/µL	Standard Error 0.079
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	-0.23 x 10^3 c/µL	Standard Error 0.101
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	-0.11 x 10^3 c/µL	Standard Error 0.09
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.06 x 10^3 c/µL	Standard Error 0.105
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	-0.04 x 10^3 c/µL	Standard Error 0.092
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	-0.05 x 10^3 c/µL	Standard Error 0.094
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	-0.03 x 10^3 c/µL	Standard Error 0.059
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.01 x 10^3 c/µL	Standard Error 0.059
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.04 x 10^3 c/µL	Standard Error 0.04
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.06 x 10^3 c/µL	Standard Error 0.094
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.09 x 10^3 c/µL	Standard Error 0.067
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	-0.11 x 10^3 c/µL	Standard Error 0.052
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	-0.08 x 10^3 c/µL	Standard Error 0.113
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.00 x 10^3 c/µL	Standard Error 0.086
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.08 x 10^3 c/µL	Standard Error 0.069
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.01 x 10^3 c/µL	Standard Error 0.061
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.01 x 10^3 c/µL	Standard Error 0.101
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	-0.14 x 10^3 c/µL	Standard Error 0.096
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.06 x 10^3 c/µL	Standard Error 0.058
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.02 x 10^3 c/µL	Standard Error 0.058
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.13 x 10^3 c/µL	Standard Error 0.049
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	-0.16 x 10^3 c/µL	Standard Error 0.084
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.05 x 10^3 c/µL	Standard Error 0.068
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.00 x 10^3 c/µL	Standard Error 0.053
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	2.22 x 10^3 c/µL	Standard Error 0.063
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.23 x 10^3 c/µL	Standard Error 0.083
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.20 x 10^3 c/µL	Standard Error 0.072
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	-0.16 x 10^3 c/µL	Standard Error 0.063
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.05 x 10^3 c/µL	Standard Error 0.102
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 48, 51, 40)	-0.16 x 10^3 c/µL	Standard Error 0.071
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.03 x 10^3 c/µL	Standard Error 0.059
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	-0.08 x 10^3 c/µL	Standard Error 0.066
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.09 x 10^3 c/µL	Standard Error 0.048
Placebo	Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.10 x 10^3 c/µL	Standard Error 0.1

Other Pre-specified

Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.31 x 10^3 c/µL	Standard Error 0.016
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.09 x 10^3 c/µL	Standard Error 0.039
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.07 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	0.03 x 10^3 c/µL	Standard Error 0.016
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.12 x 10^3 c/µL	Standard Error 0.033
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.08 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.12 x 10^3 c/µL	Standard Error 0.026
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.06 x 10^3 c/µL	Standard Error 0.022
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.14 x 10^3 c/µL	Standard Error 0.025
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.11 x 10^3 c/µL	Standard Error 0.023
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.08 x 10^3 c/µL	Standard Error 0.02
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.08 x 10^3 c/µL	Standard Error 0.028
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.05 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.05 x 10^3 c/µL	Standard Error 0.033
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.09 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	0.05 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.07 x 10^3 c/µL	Standard Error 0.029
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.06 x 10^3 c/µL	Standard Error 0.018
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.06 x 10^3 c/µL	Standard Error 0.018
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.10 x 10^3 c/µL	Standard Error 0.025
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.04 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.08 x 10^3 c/µL	Standard Error 0.023
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.05 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.08 x 10^3 c/µL	Standard Error 0.029
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	0.04 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.05 x 10^3 c/µL	Standard Error 0.02
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	0.01 x 10^3 c/µL	Standard Error 0.015
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.12 x 10^3 c/µL	Standard Error 0.031
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.04 x 10^3 c/µL	Standard Error 0.044
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.02 x 10^3 c/µL	Standard Error 0.022
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.06 x 10^3 c/µL	Standard Error 0.022
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.05 x 10^3 c/µL	Standard Error 0.026
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.02 x 10^3 c/µL	Standard Error 0.03
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.03 x 10^3 c/µL	Standard Error 0.02
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	0.01 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.05 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.04 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.05 x 10^3 c/µL	Standard Error 0.022
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	0.03 x 10^3 c/µL	Standard Error 0.018
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.04 x 10^3 c/µL	Standard Error 0.028
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	0.00 x 10^3 c/µL	Standard Error 0.014
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.04 x 10^3 c/µL	Standard Error 0.028
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.05 x 10^3 c/µL	Standard Error 0.037
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.01 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.05 x 10^3 c/µL	Standard Error 0.025
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.03 x 10^3 c/µL	Standard Error 0.026
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	0.01 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.04 x 10^3 c/µL	Standard Error 0.041
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.05 x 10^3 c/µL	Standard Error 0.034
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.04 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.34 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.04 x 10^3 c/µL	Standard Error 0.031
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.03 x 10^3 c/µL	Standard Error 0.022
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.00 x 10^3 c/µL	Standard Error 0.018
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.02 x 10^3 c/µL	Standard Error 0.018
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.04 x 10^3 c/µL	Standard Error 0.036
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.06 x 10^3 c/µL	Standard Error 0.024
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.32 x 10^3 c/µL	Standard Error 0.016
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.05 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	-0.01 x 10^3 c/µL	Standard Error 0.02
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.01 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.01 x 10^3 c/µL	Standard Error 0.017
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.04 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.00 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.03 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.04 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.06 x 10^3 c/µL	Standard Error 0.018
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.04 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.06 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	0.03 x 10^3 c/µL	Standard Error 0.019
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.04 x 10^3 c/µL	Standard Error 0.021
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.04 x 10^3 c/µL	Standard Error 0.02
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.05 x 10^3 c/µL	Standard Error 0.022
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.07 x 10^3 c/µL	Standard Error 0.026
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.08 x 10^3 c/µL	Standard Error 0.022
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.09 x 10^3 c/µL	Standard Error 0.028
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.06 x 10^3 c/µL	Standard Error 0.029
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.07 x 10^3 c/µL	Standard Error 0.026
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.10 x 10^3 c/µL	Standard Error 0.028
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.06 x 10^3 c/µL	Standard Error 0.035
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.10 x 10^3 c/µL	Standard Error 0.036
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.11 x 10^3 c/µL	Standard Error 0.04
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.11 x 10^3 c/µL	Standard Error 0.036
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.13 x 10^3 c/µL	Standard Error 0.042
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.03 x 10^3 c/µL	Standard Error 0.018
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	0.03 x 10^3 c/µL	Standard Error 0.019
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	0.01 x 10^3 c/µL	Standard Error 0.015
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.07 x 10^3 c/µL	Standard Error 0.022
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.05 x 10^3 c/µL	Standard Error 0.021
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.01 x 10^3 c/µL	Standard Error 0.022
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.09 x 10^3 c/µL	Standard Error 0.023
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.10 x 10^3 c/µL	Standard Error 0.024
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.04 x 10^3 c/µL	Standard Error 0.021
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.01 x 10^3 c/µL	Standard Error 0.017
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.13 x 10^3 c/µL	Standard Error 0.023
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.08 x 10^3 c/µL	Standard Error 0.022
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.04 x 10^3 c/µL	Standard Error 0.021
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.01 x 10^3 c/µL	Standard Error 0.018
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.01 x 10^3 c/µL	Standard Error 0.018
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.11 x 10^3 c/µL	Standard Error 0.023
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.03 x 10^3 c/µL	Standard Error 0.024
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	-0.02 x 10^3 c/µL	Standard Error 0.018
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	0.32 x 10^3 c/µL	Standard Error 0.015
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.05 x 10^3 c/µL	Standard Error 0.028
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.05 x 10^3 c/µL	Standard Error 0.02
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.07 x 10^3 c/µL	Standard Error 0.019
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.11 x 10^3 c/µL	Standard Error 0.021
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.07 x 10^3 c/µL	Standard Error 0.025
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.06 x 10^3 c/µL	Standard Error 0.018
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.00 x 10^3 c/µL	Standard Error 0.02
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.02 x 10^3 c/µL	Standard Error 0.019
Placebo	Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.13 x 10^3 c/µL	Standard Error 0.03

Other Pre-specified

Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.13 x 10^3 c/µL	Standard Error 0.146
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.34 x 10^3 c/µL	Standard Error 0.181
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.03 x 10^3 c/µL	Standard Error 0.144
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	0.02 x 10^3 c/µL	Standard Error 0.11
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.28 x 10^3 c/µL	Standard Error 0.219
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.11 x 10^3 c/µL	Standard Error 0.14
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.05 x 10^3 c/µL	Standard Error 0.161
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.19 x 10^3 c/µL	Standard Error 0.212
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.58 x 10^3 c/µL	Standard Error 0.208
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.18 x 10^3 c/µL	Standard Error 0.135
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.23 x 10^3 c/µL	Standard Error 0.22
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.01 x 10^3 c/µL	Standard Error 0.135
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.15 x 10^3 c/µL	Standard Error 0.218
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.07 x 10^3 c/µL	Standard Error 0.158
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.06 x 10^3 c/µL	Standard Error 0.122
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	-0.04 x 10^3 c/µL	Standard Error 0.211
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.17 x 10^3 c/µL	Standard Error 0.116
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.23 x 10^3 c/µL	Standard Error 0.12
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.01 x 10^3 c/µL	Standard Error 0.105
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.25 x 10^3 c/µL	Standard Error 0.223
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.19 x 10^3 c/µL	Standard Error 0.131
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.44 x 10^3 c/µL	Standard Error 0.155
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	0.09 x 10^3 c/µL	Standard Error 0.114
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.41 x 10^3 c/µL	Standard Error 0.168
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	0.09 x 10^3 c/µL	Standard Error 0.124
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.04 x 10^3 c/µL	Standard Error 0.124
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	4.00 x 10^3 c/µL	Standard Error 0.141
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.61 x 10^3 c/µL	Standard Error 0.202
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.32 x 10^3 c/µL	Standard Error 0.141
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.42 x 10^3 c/µL	Standard Error 0.171
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.64 x 10^3 c/µL	Standard Error 0.119
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.81 x 10^3 c/µL	Standard Error 0.165
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.08 x 10^3 c/µL	Standard Error 0.277
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.40 x 10^3 c/µL	Standard Error 0.182
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.80 x 10^3 c/µL	Standard Error 0.254
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	0.57 x 10^3 c/µL	Standard Error 0.263
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.49 x 10^3 c/µL	Standard Error 0.132
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.25 x 10^3 c/µL	Standard Error 0.176
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	0.27 x 10^3 c/µL	Standard Error 0.131
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.43 x 10^3 c/µL	Standard Error 0.215
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	0.11 x 10^3 c/µL	Standard Error 0.117
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.33 x 10^3 c/µL	Standard Error 0.204
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	0.16 x 10^3 c/µL	Standard Error 0.103
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.39 x 10^3 c/µL	Standard Error 0.225
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.58 x 10^3 c/µL	Standard Error 0.16
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.18 x 10^3 c/µL	Standard Error 0.178
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	3.98 x 10^3 c/µL	Standard Error 0.142
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.50 x 10^3 c/µL	Standard Error 0.293
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.67 x 10^3 c/µL	Standard Error 0.149
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.48 x 10^3 c/µL	Standard Error 0.145
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.63 x 10^3 c/µL	Standard Error 0.389
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.19 x 10^3 c/µL	Standard Error 0.097
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.59 x 10^3 c/µL	Standard Error 0.244
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.21 x 10^3 c/µL	Standard Error 0.13
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.29 x 10^3 c/µL	Standard Error 0.155
Saxagliptin 5 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.56 x 10^3 c/µL	Standard Error 0.239
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.08 x 10^3 c/µL	Standard Error 0.146
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	0.05 x 10^3 c/µL	Standard Error 0.121
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	4.16 x 10^3 c/µL	Standard Error 0.137
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	0.00 x 10^3 c/µL	Standard Error 0.101
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.04 x 10^3 c/µL	Standard Error 0.114
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	0.03 x 10^3 c/µL	Standard Error 0.096
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.17 x 10^3 c/µL	Standard Error 0.139
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.18 x 10^3 c/µL	Standard Error 0.115
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.17 x 10^3 c/µL	Standard Error 0.115
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.16 x 10^3 c/µL	Standard Error 0.132
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.32 x 10^3 c/µL	Standard Error 0.13
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.07 x 10^3 c/µL	Standard Error 0.13
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.44 x 10^3 c/µL	Standard Error 0.153
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	0.16 x 10^3 c/µL	Standard Error 0.13
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.32 x 10^3 c/µL	Standard Error 0.122
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.24 x 10^3 c/µL	Standard Error 0.165
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.19 x 10^3 c/µL	Standard Error 0.128
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.08 x 10^3 c/µL	Standard Error 0.168
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.05 x 10^3 c/µL	Standard Error 0.136
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.24 x 10^3 c/µL	Standard Error 0.114
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.29 x 10^3 c/µL	Standard Error 0.178
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.56 x 10^3 c/µL	Standard Error 0.209
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.45 x 10^3 c/µL	Standard Error 0.161
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.47 x 10^3 c/µL	Standard Error 0.162
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.27 x 10^3 c/µL	Standard Error 0.193
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.55 x 10^3 c/µL	Standard Error 0.2
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	0.51 x 10^3 c/µL	Standard Error 0.166
Saxagliptin 10 mg	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.90 x 10^3 c/µL	Standard Error 0.284
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=76, 78, 79, 67)	0.00 x 10^3 c/µL	Standard Error 0.114
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 81, 78, 74)	-0.03 x 10^3 c/µL	Standard Error 0.115
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.07 x 10^3 c/µL	Standard Error 0.131
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.22 x 10^3 c/µL	Standard Error 0.245
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 75, 65)	0.32 x 10^3 c/µL	Standard Error 0.13
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.15 x 10^3 c/µL	Standard Error 0.127
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.31 x 10^3 c/µL	Standard Error 0.235
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 38, 34, 28)	0.40 x 10^3 c/µL	Standard Error 0.198
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.21 x 10^3 c/µL	Standard Error 0.148
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.18 x 10^3 c/µL	Standard Error 0.14
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 25, 26, 23)	-0.01 x 10^3 c/µL	Standard Error 0.13
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 33, 31, 24)	0.41 x 10^3 c/µL	Standard Error 0.184
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 77, 80, 75)	0.46 x 10^3 c/µL	Standard Error 0.161
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.30 x 10^3 c/µL	Standard Error 0.139
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	4.01 x 10^3 c/µL	Standard Error 0.148
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.33 x 10^3 c/µL	Standard Error 0.176
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.45 x 10^3 c/µL	Standard Error 0.169
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 88, 90, 79)	0.19 x 10^3 c/µL	Standard Error 0.126
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=91, 99, 90, 90)	0.23 x 10^3 c/µL	Standard Error 0.12
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.01 x 10^3 c/µL	Standard Error 0.185
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.01 x 10^3 c/µL	Standard Error 0.14
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.16 x 10^3 c/µL	Standard Error 0.152
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.51 x 10^3 c/µL	Standard Error 0.271
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 50, 40)	0.01 x 10^3 c/µL	Standard Error 0.176
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.27 x 10^3 c/µL	Standard Error 0.161
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 72, 70, 60)	0.20 x 10^3 c/µL	Standard Error 0.137
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.17 x 10^3 c/µL	Standard Error 0.15
Placebo	Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.42 x 10^3 c/µL	Standard Error 0.223

Other Pre-specified

Baseline and Changes From Baseline in Hematocrit During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	42.5 percentage red blood cells	Standard Error 0.35
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	0.6 percentage red blood cells	Standard Error 0.65
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	0.1 percentage red blood cells	Standard Error 0.29
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.5 percentage red blood cells	Standard Error 0.22
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.0 percentage red blood cells	Standard Error 0.42
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.3 percentage red blood cells	Standard Error 0.34
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	0.7 percentage red blood cells	Standard Error 0.39
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	0.0 percentage red blood cells	Standard Error 0.3
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.2 percentage red blood cells	Standard Error 0.37
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	0.9 percentage red blood cells	Standard Error 0.37
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	0.6 percentage red blood cells	Standard Error 0.25
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	1.1 percentage red blood cells	Standard Error 0.55
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.6 percentage red blood cells	Standard Error 0.25
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	-0.4 percentage red blood cells	Standard Error 0.54
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	0.6 percentage red blood cells	Standard Error 0.27
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.2 percentage red blood cells	Standard Error 0.21
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.1 percentage red blood cells	Standard Error 0.53
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 16 (n=90. 91, 83, 71)	0.5 percentage red blood cells	Standard Error 0.24
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.2 percentage red blood cells	Standard Error 0.27
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	-0.8 percentage red blood cells	Standard Error 0.45
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	0.7 percentage red blood cells	Standard Error 0.25
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	0.3 percentage red blood cells	Standard Error 0.27
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.1 percentage red blood cells	Standard Error 0.19
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.1 percentage red blood cells	Standard Error 0.42
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	0.0 percentage red blood cells	Standard Error 0.24
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	0.5 percentage red blood cells	Standard Error 0.3
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87)	-0.4 percentage red blood cells	Standard Error 0.22
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	0.2 percentage red blood cells	Standard Error 0.42
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	1.1 percentage red blood cells	Standard Error 0.55
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.1 percentage red blood cells	Standard Error 0.27
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	0.6 percentage red blood cells	Standard Error 0.27
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	0.6 percentage red blood cells	Standard Error 0.42
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.1 percentage red blood cells	Standard Error 0.48
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	0.3 percentage red blood cells	Standard Error 0.33
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	0.2 percentage red blood cells	Standard Error 0.28
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	0.2 percentage red blood cells	Standard Error 0.32
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 16 (n=90. 91, 83, 71)	0.7 percentage red blood cells	Standard Error 0.26
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.1 percentage red blood cells	Standard Error 0.31
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.4 percentage red blood cells	Standard Error 0.27
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	0.5 percentage red blood cells	Standard Error 0.4
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.2 percentage red blood cells	Standard Error 0.24
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	0.5 percentage red blood cells	Standard Error 0.4
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	-0.8 percentage red blood cells	Standard Error 0.43
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.3 percentage red blood cells	Standard Error 0.24
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.4 percentage red blood cells	Standard Error 0.29
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	0.9 percentage red blood cells	Standard Error 0.34
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87)	-0.2 percentage red blood cells	Standard Error 0.2
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.6 percentage red blood cells	Standard Error 0.58
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	0.2 percentage red blood cells	Standard Error 0.52
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	-0.0 percentage red blood cells	Standard Error 0.31
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	42.8 percentage red blood cells	Standard Error 0.35
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	0.3 percentage red blood cells	Standard Error 0.43
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.1 percentage red blood cells	Standard Error 0.36
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.4 percentage red blood cells	Standard Error 0.26
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	0.4 percentage red blood cells	Standard Error 0.31
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	0.2 percentage red blood cells	Standard Error 0.46
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	0.7 percentage red blood cells	Standard Error 0.35
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	42.7 percentage red blood cells	Standard Error 0.37
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87)	-0.7 percentage red blood cells	Standard Error 0.21
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.1 percentage red blood cells	Standard Error 0.22
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.0 percentage red blood cells	Standard Error 0.24
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.2 percentage red blood cells	Standard Error 0.2
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	-0.2 percentage red blood cells	Standard Error 0.24
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.6 percentage red blood cells	Standard Error 0.26
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	0.2 percentage red blood cells	Standard Error 0.27
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 16 (n=90. 91, 83, 71)	0.6 percentage red blood cells	Standard Error 0.25
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.3 percentage red blood cells	Standard Error 0.24
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	0.1 percentage red blood cells	Standard Error 0.26
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.3 percentage red blood cells	Standard Error 0.26
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.1 percentage red blood cells	Standard Error 0.24
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	0.2 percentage red blood cells	Standard Error 0.3
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	0.4 percentage red blood cells	Standard Error 0.29
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	0.1 percentage red blood cells	Standard Error 0.34
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.6 percentage red blood cells	Standard Error 0.34
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	1.2 percentage red blood cells	Standard Error 0.35
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.0 percentage red blood cells	Standard Error 0.34
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	0.2 percentage red blood cells	Standard Error 0.46
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	0.0 percentage red blood cells	Standard Error 0.43
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	0.2 percentage red blood cells	Standard Error 0.5
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	-1.0 percentage red blood cells	Standard Error 0.51
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	0.2 percentage red blood cells	Standard Error 0.56
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	1.0 percentage red blood cells	Standard Error 0.53
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	0.5 percentage red blood cells	Standard Error 0.61
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	0.2 percentage red blood cells	Standard Error 0.42
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	0.4 percentage red blood cells	Standard Error 0.35
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	0.5 percentage red blood cells	Standard Error 0.32
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	0.3 percentage red blood cells	Standard Error 0.21
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.1 percentage red blood cells	Standard Error 0.42
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	0.5 percentage red blood cells	Standard Error 0.32
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	0.2 percentage red blood cells	Standard Error 0.27
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	-0.5 percentage red blood cells	Standard Error 0.52
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.2 percentage red blood cells	Standard Error 0.41
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.4 percentage red blood cells	Standard Error 0.3
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 16 (n=90. 91, 83, 71)	0.3 percentage red blood cells	Standard Error 0.3
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.0 percentage red blood cells	Standard Error 0.59
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	-0.3 percentage red blood cells	Standard Error 0.43
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	0.2 percentage red blood cells	Standard Error 0.26
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.7 percentage red blood cells	Standard Error 0.25
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87)	-0.4 percentage red blood cells	Standard Error 0.23
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.4 percentage red blood cells	Standard Error 0.48
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	0.5 percentage red blood cells	Standard Error 0.32
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.5 percentage red blood cells	Standard Error 0.25
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	42.8 percentage red blood cells	Standard Error 0.35
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	0.4 percentage red blood cells	Standard Error 0.36
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	0.8 percentage red blood cells	Standard Error 0.34
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.7 percentage red blood cells	Standard Error 0.43
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.5 percentage red blood cells	Standard Error 0.57
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.7 percentage red blood cells	Standard Error 0.36
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	0.2 percentage red blood cells	Standard Error 0.27
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.4 percentage red blood cells	Standard Error 0.33
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.3 percentage red blood cells	Standard Error 0.25
Placebo	Baseline and Changes From Baseline in Hematocrit During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	0.2 percentage red blood cells	Standard Error 0.4

Other Pre-specified

Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	-0.16 g/dL	Standard Error 0.079
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.31 g/dL	Standard Error 0.094
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	-0.17 g/dL	Standard Error 0.082
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.45 g/dL	Standard Error 0.212
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.41 g/dL	Standard Error 0.132
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	-0.18 g/dL	Standard Error 0.112
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	-0.00 g/dL	Standard Error 0.068
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	-0.27 g/dL	Standard Error 0.125
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.32 g/dL	Standard Error 0.132
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.18 g/dL	Standard Error 0.109
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87)	-0.21 g/dL	Standard Error 0.069
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	0.01 g/dL	Standard Error 0.082
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.38 g/dL	Standard Error 0.178
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	-0.04 g/dL	Standard Error 0.074
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	-0.09 g/dL	Standard Error 0.09
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	-0.51 g/dL	Standard Error 0.221
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.51 g/dL	Standard Error 0.178
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	-0.10 g/dL	Standard Error 0.087
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.16 g/dL	Standard Error 0.071
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.26 g/dL	Standard Error 0.083
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	-0.45 g/dL	Standard Error 0.16
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.38 g/dL	Standard Error 0.125
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	14.49 g/dL	Standard Error 0.133
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.35 g/dL	Standard Error 0.075
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.40 g/dL	Standard Error 0.125
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.37 g/dL	Standard Error 0.079
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	-0.12 g/dL	Standard Error 0.069
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.25 g/dL	Standard Error 0.081
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.05 g/dL	Standard Error 0.161
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	-0.14 g/dL	Standard Error 0.093
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.22 g/dL	Standard Error 0.087
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	-0.07 g/dL	Standard Error 0.195
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.07 g/dL	Standard Error 0.137
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	-0.05 g/dL	Standard Error 0.078
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	0.06 g/dL	Standard Error 0.103
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.25 g/dL	Standard Error 0.08
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.35 g/dL	Standard Error 0.156
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.29 g/dL	Standard Error 0.097
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	-0.11 g/dL	Standard Error 0.096
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.01 g/dL	Standard Error 0.078
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.00 g/dL	Standard Error 0.129
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.23 g/dL	Standard Error 0.092
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	-0.19 g/dL	Standard Error 0.119
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.04 g/dL	Standard Error 0.08
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	-0.37 g/dL	Standard Error 0.186
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.03 g/dL	Standard Error 0.19
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.09 g/dL	Standard Error 0.097
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.10 g/dL	Standard Error 0.079
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.08 g/dL	Standard Error 0.176
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.15 g/dL	Standard Error 0.082
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	-0.20 g/dL	Standard Error 0.096
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87)	-0.13 g/dL	Standard Error 0.065
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.17 g/dL	Standard Error 0.128
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	-0.00 g/dL	Standard Error 0.074
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	-0.07 g/dL	Standard Error 0.079
Saxagliptin 5 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	14.45 g/dL	Standard Error 0.125
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.18 g/dL	Standard Error 0.147
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	14.47 g/dL	Standard Error 0.137
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87)	-0.22 g/dL	Standard Error 0.075
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.09 g/dL	Standard Error 0.069
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	-0.07 g/dL	Standard Error 0.073
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	-0.02 g/dL	Standard Error 0.071
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	-0.13 g/dL	Standard Error 0.086
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	-0.07 g/dL	Standard Error 0.083
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	-0.12 g/dL	Standard Error 0.085
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.00 g/dL	Standard Error 0.087
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.07 g/dL	Standard Error 0.092
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	-0.25 g/dL	Standard Error 0.081
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.36 g/dL	Standard Error 0.087
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.32 g/dL	Standard Error 0.078
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.19 g/dL	Standard Error 0.086
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.06 g/dL	Standard Error 0.09
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	-0.02 g/dL	Standard Error 0.107
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.07 g/dL	Standard Error 0.102
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	-0.07 g/dL	Standard Error 0.102
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.04 g/dL	Standard Error 0.103
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.07 g/dL	Standard Error 0.121
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.16 g/dL	Standard Error 0.178
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.25 g/dL	Standard Error 0.132
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.15 g/dL	Standard Error 0.169
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	-0.24 g/dL	Standard Error 0.166
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.03 g/dL	Standard Error 0.17
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.08 g/dL	Standard Error 0.167
Saxagliptin 10 mg	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	0.10 g/dL	Standard Error 0.124
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.19 g/dL	Standard Error 0.116
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.18 g/dL	Standard Error 0.101
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.14 g/dL	Standard Error 0.1
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	0.10 g/dL	Standard Error 0.063
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.33 g/dL	Standard Error 0.124
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.18 g/dL	Standard Error 0.102
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	-0.19 g/dL	Standard Error 0.086
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.39 g/dL	Standard Error 0.175
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.36 g/dL	Standard Error 0.104
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	-0.03 g/dL	Standard Error 0.099
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.04 g/dL	Standard Error 0.084
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87)	-0.09 g/dL	Standard Error 0.078
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	-0.25 g/dL	Standard Error 0.13
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	-0.03 g/dL	Standard Error 0.083
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.16 g/dL	Standard Error 0.075
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	14.50 g/dL	Standard Error 0.131
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.24 g/dL	Standard Error 0.148
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	0.04 g/dL	Standard Error 0.097
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.09 g/dL	Standard Error 0.074
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	-0.32 g/dL	Standard Error 0.174
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.10 g/dL	Standard Error 0.109
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	-0.10 g/dL	Standard Error 0.117
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.08 g/dL	Standard Error 0.139
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.61 g/dL	Standard Error 0.169
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.29 g/dL	Standard Error 0.131
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	-0.01 g/dL	Standard Error 0.1
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.33 g/dL	Standard Error 0.093
Placebo	Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.04 g/dL	Standard Error 0.069

Other Pre-specified

Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Baseline (BL) (Week 0) (n=101, 106, 96, 94)	251.1 x 10^9 c/L	Standard Error 6.33
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 193 (n=17, 25, 25, 22)	-13.6 x 10^9 c/L	Standard Error 8.11
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 50 (n=66, 67, 66, 59)	-2.5 x 10^9 c/L	Standard Error 4.25
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 8 (n=86, 85, 86, 77)	0.4 x 10^9 c/L	Standard Error 3.21
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 115 (n=33, 41, 41, 34)	5.0 x 10^9 c/L	Standard Error 8.04
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 63 (n=59, 64, 65, 54)	-3.1 x 10^9 c/L	Standard Error 4.57
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 76 (n=50, 58, 61, 49)	-2.0 x 10^9 c/L	Standard Error 5.64
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 37 (n=70, 68, 66, 59)	-14.3 x 10^9 c/L	Standard Error 3.85
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 49, 39)	3.2 x 10^9 c/L	Standard Error 7.75
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 89 (n=47, 56, 54, 42)	3.5 x 10^9 c/L	Standard Error 5.29
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 10 (n=68, 75, 67, 62)	-0.8 x 10^9 c/L	Standard Error 3.87
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 180 (n=20, 27, 27, 25)	-11.1 x 10^9 c/L	Standard Error 6.57
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 12 (n=83, 84, 85, 82)	-6.3 x 10^9 c/L	Standard Error 3.58
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 206 (n=15, 21, 23, 21)	-2.6 x 10^9 c/L	Standard Error 10.45
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 14 (n=72, 79, 77, 74)	1.2 x 10^9 c/L	Standard Error 3.91
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 4 (n=88, 97, 90, 90)	11.2 x 10^9 c/L	Standard Error 3.39
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 167 (n=22, 32, 28, 26)	-18.0 x 10^9 c/L	Standard Error 6.71
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 16 (n=86, 88, 81, 69)	-2.3 x 10^9 c/L	Standard Error 3.73
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 18 (n=77, 71, 79, 70)	-1.1 x 10^9 c/L	Standard Error 3.93
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 154 (n=25, 35, 31, 23)	5.0 x 10^9 c/L	Standard Error 6.95
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 20 (n=78, 78, 72, 70)	-1.9 x 10^9 c/L	Standard Error 3.87
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 22 (n=74, 72, 73, 62)	0.3 x 10^9 c/L	Standard Error 4.64
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 6 (n=88, 93, 84, 81)	4.3 x 10^9 c/L	Standard Error 2.85
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 141 (n=27, 39, 33, 27)	-1.1 x 10^9 c/L	Standard Error 5.34
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 24 (n=80, 76, 73, 72)	-7.1 x 10^9 c/L	Standard Error 3.94
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 30 (n=73, 74, 74, 67)	-2.0 x 10^9 c/L	Standard Error 5.66
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 2 (n=92, 96, 85, 82)	1.8 x 10^9 c/L	Standard Error 3.4
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 128 (n=30, 38, 39, 30)	3.8 x 10^9 c/L	Standard Error 5.74
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 193 (n=17, 25, 25, 22)	-13.4 x 10^9 c/L	Standard Error 9.58
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 37 (n=70, 68, 66, 59)	-8.1 x 10^9 c/L	Standard Error 4.71
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 14 (n=72, 79, 77, 74)	3.2 x 10^9 c/L	Standard Error 4.75
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 115 (n=33, 41, 41, 34)	-8.8 x 10^9 c/L	Standard Error 4.96
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 141 (n=27, 39, 33, 27)	-4.6 x 10^9 c/L	Standard Error 5.16
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 50 (n=66, 67, 66, 59)	-5.6 x 10^9 c/L	Standard Error 4.39
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 24 (n=80, 76, 73, 72)	-6.0 x 10^9 c/L	Standard Error 4
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 22 (n=74, 72, 73, 62)	-2.5 x 10^9 c/L	Standard Error 3.91
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 16 (n=86, 88, 81, 69)	1.1 x 10^9 c/L	Standard Error 3.66
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 63 (n=59, 64, 65, 54)	-3.4 x 10^9 c/L	Standard Error 4.24
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 8 (n=86, 85, 86, 77)	1.0 x 10^9 c/L	Standard Error 3.13
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 49, 39)	-2.3 x 10^9 c/L	Standard Error 5.34
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 4 (n=88, 97, 90, 90)	8.6 x 10^9 c/L	Standard Error 3.41
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 76 (n=50, 58, 61, 49)	-1.5 x 10^9 c/L	Standard Error 4.56
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 154 (n=25, 35, 31, 23)	5.8 x 10^9 c/L	Standard Error 7.2
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 6 (n=88, 93, 84, 81)	4.3 x 10^9 c/L	Standard Error 3.53
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 18 (n=77, 71, 79, 70)	2.0 x 10^9 c/L	Standard Error 4.06
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 89 (n=47, 56, 54, 42)	1.9 x 10^9 c/L	Standard Error 5.02
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 2 (n=92, 96, 85, 82)	4.4 x 10^9 c/L	Standard Error 2.82
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 180 (n=20, 27, 27, 25)	-24.0 x 10^9 c/L	Standard Error 6.18
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 206 (n=15, 21, 23, 21)	-18.7 x 10^9 c/L	Standard Error 9.01
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 10 (n=68, 75, 67, 62)	3.0 x 10^9 c/L	Standard Error 3.99
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Baseline (BL) (Week 0) (n=101, 106, 96, 94)	253.1 x 10^9 c/L	Standard Error 5.93
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 128 (n=30, 38, 39, 30)	-2.1 x 10^9 c/L	Standard Error 5.39
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 30 (n=73, 74, 74, 67)	-3.3 x 10^9 c/L	Standard Error 4.37
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 12 (n=83, 84, 85, 82)	-1.3 x 10^9 c/L	Standard Error 3.85
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 20 (n=78, 78, 72, 70)	-4.8 x 10^9 c/L	Standard Error 4.39
Saxagliptin 5 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 167 (n=22, 32, 28, 26)	-0.1 x 10^9 c/L	Standard Error 6.99
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 76 (n=50, 58, 61, 49)	-6.0 x 10^9 c/L	Standard Error 3.68
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Baseline (BL) (Week 0) (n=101, 106, 96, 94)	261.6 x 10^9 c/L	Standard Error 6.71
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 2 (n=92, 96, 85, 82)	2.2 x 10^9 c/L	Standard Error 3.72
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 4 (n=88, 97, 90, 90)	5.6 x 10^9 c/L	Standard Error 3.11
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 6 (n=88, 93, 84, 81)	-0.2 x 10^9 c/L	Standard Error 3.39
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 8 (n=86, 85, 86, 77)	-4.3 x 10^9 c/L	Standard Error 2.94
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 10 (n=68, 75, 67, 62)	-4.4 x 10^9 c/L	Standard Error 4.44
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 12 (n=83, 84, 85, 82)	-4.8 x 10^9 c/L	Standard Error 4.14
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 14 (n=72, 79, 77, 74)	-3.7 x 10^9 c/L	Standard Error 4.21
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 16 (n=86, 88, 81, 69)	-6.0 x 10^9 c/L	Standard Error 3.74
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 18 (n=77, 71, 79, 70)	-2.7 x 10^9 c/L	Standard Error 3.63
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 20 (n=78, 78, 72, 70)	-8.3 x 10^9 c/L	Standard Error 3.94
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 22 (n=74, 72, 73, 62)	-5.4 x 10^9 c/L	Standard Error 4.01
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 24 (n=80, 76, 73, 72)	-15.5 x 10^9 c/L	Standard Error 4.54
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 30 (n=73, 74, 74, 67)	-9.9 x 10^9 c/L	Standard Error 4.34
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 37 (n=70, 68, 66, 59)	-15.6 x 10^9 c/L	Standard Error 3.93
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 50 (n=66, 67, 66, 59)	-11.5 x 10^9 c/L	Standard Error 3.76
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 63 (n=59, 64, 65, 54)	-6.3 x 10^9 c/L	Standard Error 4.23
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 89 (n=47, 56, 54, 42)	-6.7 x 10^9 c/L	Standard Error 3.83
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 49, 39)	-4.8 x 10^9 c/L	Standard Error 3.65
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 115 (n=33, 41, 41, 34)	-12.0 x 10^9 c/L	Standard Error 4.23
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 128 (n=30, 38, 39, 30)	-2.6 x 10^9 c/L	Standard Error 5.04
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 141 (n=27, 39, 33, 27)	-0.3 x 10^9 c/L	Standard Error 4.73
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 154 (n=25, 35, 31, 23)	-2.9 x 10^9 c/L	Standard Error 5.25
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 167 (n=22, 32, 28, 26)	-14.6 x 10^9 c/L	Standard Error 6.21
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 180 (n=20, 27, 27, 25)	-17.3 x 10^9 c/L	Standard Error 6.54
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 193 (n=17, 25, 25, 22)	-13.4 x 10^9 c/L	Standard Error 6
Saxagliptin 10 mg	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 206 (n=15, 21, 23, 21)	6.2 x 10^9 c/L	Standard Error 9.35
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 30 (n=73, 74, 74, 67)	4.5 x 10^9 c/L	Standard Error 4.08
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 24 (n=80, 76, 73, 72)	-3.0 x 10^9 c/L	Standard Error 3.66
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 4 (n=88, 97, 90, 90)	11.3 x 10^9 c/L	Standard Error 2.94
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 128 (n=30, 38, 39, 30)	2.6 x 10^9 c/L	Standard Error 7.91
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 22 (n=74, 72, 73, 62)	5.0 x 10^9 c/L	Standard Error 3.48
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 20 (n=78, 78, 72, 70)	-1.3 x 10^9 c/L	Standard Error 3.38
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 206 (n=15, 21, 23, 21)	-6.1 x 10^9 c/L	Standard Error 11.49
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 141 (n=27, 39, 33, 27)	-1.3 x 10^9 c/L	Standard Error 8.24
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 18 (n=77, 71, 79, 70)	5.8 x 10^9 c/L	Standard Error 3.79
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 16 (n=86, 88, 81, 69)	3.2 x 10^9 c/L	Standard Error 3.72
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 193 (n=17, 25, 25, 22)	-12.0 x 10^9 c/L	Standard Error 7.27
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 154 (n=25, 35, 31, 23)	8.8 x 10^9 c/L	Standard Error 13.59
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 14 (n=72, 79, 77, 74)	5.2 x 10^9 c/L	Standard Error 3.59
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 12 (n=83, 84, 85, 82)	4.0 x 10^9 c/L	Standard Error 3.21
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 2 (n=92, 96, 85, 82)	9.5 x 10^9 c/L	Standard Error 3.47
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 167 (n=22, 32, 28, 26)	4.3 x 10^9 c/L	Standard Error 8.63
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 10 (n=68, 75, 67, 62)	7.1 x 10^9 c/L	Standard Error 3.53
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 8 (n=86, 85, 86, 77)	4.0 x 10^9 c/L	Standard Error 4.26
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Baseline (BL) (Week 0) (n=101, 106, 96, 94)	259.8 x 10^9 c/L	Standard Error 6.25
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 89 (n=47, 56, 54, 42)	2.7 x 10^9 c/L	Standard Error 4.97
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 76 (n=50, 58, 61, 49)	1.2 x 10^9 c/L	Standard Error 4.88
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 63 (n=59, 64, 65, 54)	10.2 x 10^9 c/L	Standard Error 5.37
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 180 (n=20, 27, 27, 25)	4.0 x 10^9 c/L	Standard Error 10.72
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 49, 39)	9.7 x 10^9 c/L	Standard Error 7.21
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 50 (n=66, 67, 66, 59)	6.6 x 10^9 c/L	Standard Error 6.29
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 37 (n=70, 68, 66, 59)	0.1 x 10^9 c/L	Standard Error 4.81
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 6 (n=88, 93, 84, 81)	9.5 x 10^9 c/L	Standard Error 3.05
Placebo	Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period	Change from BL at Week 115 (n=33, 41, 41, 34)	9.2 x 10^9 c/L	Standard Error 7.57

Other Pre-specified

Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	4.80 x 10^6 c/µL	Standard Error 0.038
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.05 x 10^6 c/µL	Standard Error 0.054
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	-0.02 x 10^6 c/µL	Standard Error 0.027
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.05 x 10^6 c/µL	Standard Error 0.02
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.04 x 10^6 c/µL	Standard Error 0.039
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.00 x 10^6 c/µL	Standard Error 0.032
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	-0.07 x 10^6 c/µL	Standard Error 0.037
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.04 x 10^6 c/µL	Standard Error 0.028
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.10 x 10^6 c/µL	Standard Error 0.04
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.04 x 10^6 c/µL	Standard Error 0.034
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	0.05 x 10^6 c/µL	Standard Error 0.026
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.05 x 10^6 c/µL	Standard Error 0.041
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.05 x 10^6 c/µL	Standard Error 0.025
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	-0.03 x 10^6 c/µL	Standard Error 0.064
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	0.05 x 10^6 c/µL	Standard Error 0.027
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.01 x 10^6 c/µL	Standard Error 0.023
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.11 x 10^6 c/µL	Standard Error 0.052
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.06 x 10^6 c/µL	Standard Error 0.027
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.01 x 10^6 c/µL	Standard Error 0.024
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 35, 31, 24)	-0.13 x 10^6 c/µL	Standard Error 0.037
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	0.03 x 10^6 c/µL	Standard Error 0.023
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.01 x 10^6 c/µL	Standard Error 0.023
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.00 x 10^6 c/µL	Standard Error 0.022
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.10 x 10^6 c/µL	Standard Error 0.037
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.04 x 10^6 c/µL	Standard Error 0.024
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	0.00 x 10^6 c/µL	Standard Error 0.027
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87	-0.06 x 10^6 c/µL	Standard Error 0.021
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.05 x 10^6 c/µL	Standard Error 0.037
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.06 x 10^6 c/µL	Standard Error 0.061
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.04 x 10^6 c/µL	Standard Error 0.027
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	0.03 x 10^6 c/µL	Standard Error 0.029
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.01 x 10^6 c/µL	Standard Error 0.043
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.13 x 10^6 c/µL	Standard Error 0.048
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	0.04 x 10^6 c/µL	Standard Error 0.031
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.04 x 10^6 c/µL	Standard Error 0.029
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.01 x 10^6 c/µL	Standard Error 0.033
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.08 x 10^6 c/µL	Standard Error 0.028
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	-0.01 x 10^6 c/µL	Standard Error 0.028
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.03 x 10^6 c/µL	Standard Error 0.026
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.03 x 10^6 c/µL	Standard Error 0.043
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.04 x 10^6 c/µL	Standard Error 0.026
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	-0.07 x 10^6 c/µL	Standard Error 0.038
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 35, 31, 24)	-0.13 x 10^6 c/µL	Standard Error 0.045
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.02 x 10^6 c/µL	Standard Error 0.024
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.04 x 10^6 c/µL	Standard Error 0.029
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.06 x 10^6 c/µL	Standard Error 0.028
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87	-0.04 x 10^6 c/µL	Standard Error 0.021
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.08 x 10^6 c/µL	Standard Error 0.059
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	-0.06 x 10^6 c/µL	Standard Error 0.058
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	-0.03 x 10^6 c/µL	Standard Error 0.033
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	4.80 x 10^6 c/µL	Standard Error 0.042
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.07 x 10^6 c/µL	Standard Error 0.039
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.07 x 10^6 c/µL	Standard Error 0.035
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.03 x 10^6 c/µL	Standard Error 0.029
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	0.02 x 10^6 c/µL	Standard Error 0.031
Saxagliptin 5 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.04 x 10^6 c/µL	Standard Error 0.049
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	0.00 x 10^6 c/µL	Standard Error 0.036
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	4.82 x 10^6 c/µL	Standard Error 0.039
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87	-0.08 x 10^6 c/µL	Standard Error 0.023
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	-0.02 x 10^6 c/µL	Standard Error 0.022
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.00 x 10^6 c/µL	Standard Error 0.026
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.03 x 10^6 c/µL	Standard Error 0.023
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	-0.02 x 10^6 c/µL	Standard Error 0.026
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.07 x 10^6 c/µL	Standard Error 0.025
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	0.04 x 10^6 c/µL	Standard Error 0.03
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.08 x 10^6 c/µL	Standard Error 0.027
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.05 x 10^6 c/µL	Standard Error 0.028
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	0.01 x 10^6 c/µL	Standard Error 0.025
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.05 x 10^6 c/µL	Standard Error 0.029
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.03 x 10^6 c/µL	Standard Error 0.026
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.01 x 10^6 c/µL	Standard Error 0.031
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	0.04 x 10^6 c/µL	Standard Error 0.031
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	0.02 x 10^6 c/µL	Standard Error 0.034
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.08 x 10^6 c/µL	Standard Error 0.034
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.01 x 10^6 c/µL	Standard Error 0.035
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.03 x 10^6 c/µL	Standard Error 0.037
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.02 x 10^6 c/µL	Standard Error 0.044
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.04 x 10^6 c/µL	Standard Error 0.048
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.02 x 10^6 c/µL	Standard Error 0.052
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 35, 31, 24)	-0.08 x 10^6 c/µL	Standard Error 0.054
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.01 x 10^6 c/µL	Standard Error 0.057
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.01 x 10^6 c/µL	Standard Error 0.054
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.02 x 10^6 c/µL	Standard Error 0.057
Saxagliptin 10 mg	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	0.06 x 10^6 c/µL	Standard Error 0.043
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.03 x 10^6 c/µL	Standard Error 0.034
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.01 x 10^6 c/µL	Standard Error 0.031
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 91, 91)	0.04 x 10^6 c/µL	Standard Error 0.02
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 30)	-0.10 x 10^6 c/µL	Standard Error 0.039
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=78, 74, 76, 65)	-0.01 x 10^6 c/µL	Standard Error 0.032
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 80, 78, 72)	-0.01 x 10^6 c/µL	Standard Error 0.026
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 24, 21)	-0.08 x 10^6 c/µL	Standard Error 0.055
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	-0.11 x 10^6 c/µL	Standard Error 0.041
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.04 x 10^6 c/µL	Standard Error 0.03
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.06 x 10^6 c/µL	Standard Error 0.028
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	-0.10 x 10^6 c/µL	Standard Error 0.062
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 35, 31, 24)	-0.09 x 10^6 c/µL	Standard Error 0.045
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 80, 81, 75)	0.04 x 10^6 c/µL	Standard Error 0.025
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=85, 88, 87, 82)	0.08 x 10^6 c/µL	Standard Error 0.026
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95,100, 93, 87	-0.05 x 10^6 c/µL	Standard Error 0.023
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 26)	-0.10 x 10^6 c/µL	Standard Error 0.044
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=70, 76, 69, 63)	0.07 x 10^6 c/µL	Standard Error 0.032
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=92, 90, 91, 79)	0.05 x 10^6 c/µL	Standard Error 0.023
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	4.82 x 10^6 c/µL	Standard Error 0.043
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 42)	-0.07 x 10^6 c/µL	Standard Error 0.031
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 59, 63, 49)	-0.03 x 10^6 c/µL	Standard Error 0.037
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 67, 55)	0.05 x 10^6 c/µL	Standard Error 0.045
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	-0.17 x 10^6 c/µL	Standard Error 0.056
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=40, 49, 51, 40)	-0.13 x 10^6 c/µL	Standard Error 0.037
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 71, 71, 61)	0.01 x 10^6 c/µL	Standard Error 0.026
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=75, 73, 70, 62)	-0.09 x 10^6 c/µL	Standard Error 0.033
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=91, 96, 87, 82)	0.02 x 10^6 c/µL	Standard Error 0.023
Placebo	Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 35)	-0.06 x 10^6 c/µL	Standard Error 0.033

Other Pre-specified

Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period

Time frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	6.71 x 10^3 c/µL	Standard Error 0.179
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.11 x 10^3 c/µL	Standard Error 0.136
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.01 x 10^3 c/µL	Standard Error 0.168
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	0.34 x 10^3 c/µL	Standard Error 0.22
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.24 x 10^3 c/µL	Standard Error 0.235
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.12 x 10^3 c/µL	Standard Error 0.176
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.03 x 10^3 c/µL	Standard Error 0.185
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 73, 70, 62)	0.21 x 10^3 c/µL	Standard Error 0.163
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 51, 40)	0.16 x 10^3 c/µL	Standard Error 0.218
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.51 x 10^3 c/µL	Standard Error 0.232
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.32 x 10^3 c/µL	Standard Error 0.168
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.13 x 10^3 c/µL	Standard Error 0.233
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	-0.00 x 10^3 c/µL	Standard Error 0.148
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.01 x 10^3 c/µL	Standard Error 0.199
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 78, 80, 75)	0.33 x 10^3 c/µL	Standard Error 0.196
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 90, 90)	0.06 x 10^3 c/µL	Standard Error 0.132
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	-0.22 x 10^3 c/µL	Standard Error 0.233
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.24 x 10^3 c/µL	Standard Error 0.146
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.37 x 10^3 c/µL	Standard Error 0.166
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	0.12 x 10^3 c/µL	Standard Error 0.228
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.29 x 10^3 c/µL	Standard Error 0.15
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 89, 90, 79)	-0.02 x 10^3 c/µL	Standard Error 0.132
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 76, 65)	0.66 x 10^3 c/µL	Standard Error 0.184
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	0.35 x 10^3 c/µL	Standard Error 0.183
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	0.10 x 10^3 c/µL	Standard Error 0.149
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.01 x 10^3 c/µL	Standard Error 0.115
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	0.15 x 10^3 c/µL	Standard Error 0.148
Saxagliptin 2.5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.58 x 10^3 c/µL	Standard Error 0.227
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	0.47 x 10^3 c/µL	Standard Error 0.265
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 73, 70, 62)	0.42 x 10^3 c/µL	Standard Error 0.204
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 78, 80, 75)	0.71 x 10^3 c/µL	Standard Error 0.166
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.93 x 10^3 c/µL	Standard Error 0.252
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	0.78 x 10^3 c/µL	Standard Error 0.303
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.33 x 10^3 c/µL	Standard Error 0.216
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	0.33 x 10^3 c/µL	Standard Error 0.202
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 76, 65)	0.72 x 10^3 c/µL	Standard Error 0.178
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.54 x 10^3 c/µL	Standard Error 0.148
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.20 x 10^3 c/µL	Standard Error 0.221
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 89, 90, 79)	0.18 x 10^3 c/µL	Standard Error 0.144
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 51, 40)	0.44 x 10^3 c/µL	Standard Error 0.258
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 90, 90)	0.05 x 10^3 c/µL	Standard Error 0.125
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	0.23 x 10^3 c/µL	Standard Error 0.259
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	0.44 x 10^3 c/µL	Standard Error 0.327
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	0.02 x 10^3 c/µL	Standard Error 0.403
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.82 x 10^3 c/µL	Standard Error 0.172
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	0.17 x 10^3 c/µL	Standard Error 0.246
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	0.05 x 10^3 c/µL	Standard Error 0.132
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.30 x 10^3 c/µL	Standard Error 0.379
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.55 x 10^3 c/µL	Standard Error 0.42
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.55 x 10^3 c/µL	Standard Error 0.169
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	6.75 x 10^3 c/µL	Standard Error 0.198
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.66 x 10^3 c/µL	Standard Error 0.314
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.10 x 10^3 c/µL	Standard Error 0.126
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.09 x 10^3 c/µL	Standard Error 0.155
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.29 x 10^3 c/µL	Standard Error 0.163
Saxagliptin 5 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.44 x 10^3 c/µL	Standard Error 0.341
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.07 x 10^3 c/µL	Standard Error 0.158
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	6.82 x 10^3 c/µL	Standard Error 0.155
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.14 x 10^3 c/µL	Standard Error 0.113
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 90, 90)	-0.16 x 10^3 c/µL	Standard Error 0.132
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	-0.18 x 10^3 c/µL	Standard Error 0.128
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 89, 90, 79)	-0.17 x 10^3 c/µL	Standard Error 0.121
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.12 x 10^3 c/µL	Standard Error 0.162
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.05 x 10^3 c/µL	Standard Error 0.145
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 78, 80, 75)	0.22 x 10^3 c/µL	Standard Error 0.134
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.04 x 10^3 c/µL	Standard Error 0.138
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.42 x 10^3 c/µL	Standard Error 0.142
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.01 x 10^3 c/µL	Standard Error 0.14
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 76, 65)	0.44 x 10^3 c/µL	Standard Error 0.175
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	0.08 x 10^3 c/µL	Standard Error 0.158
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	0.28 x 10^3 c/µL	Standard Error 0.167
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 73, 70, 62)	0.12 x 10^3 c/µL	Standard Error 0.189
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	-0.03 x 10^3 c/µL	Standard Error 0.149
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	-0.04 x 10^3 c/µL	Standard Error 0.18
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	-0.10 x 10^3 c/µL	Standard Error 0.152
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 51, 40)	0.10 x 10^3 c/µL	Standard Error 0.129
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.11 x 10^3 c/µL	Standard Error 0.21
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.44 x 10^3 c/µL	Standard Error 0.221
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	0.44 x 10^3 c/µL	Standard Error 0.199
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	0.30 x 10^3 c/µL	Standard Error 0.212
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.27 x 10^3 c/µL	Standard Error 0.209
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.59 x 10^3 c/µL	Standard Error 0.263
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	0.60 x 10^3 c/µL	Standard Error 0.205
Saxagliptin 10 mg	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	1.01 x 10^3 c/µL	Standard Error 0.303
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 30 (n=77, 78, 79, 67)	-0.03 x 10^3 c/µL	Standard Error 0.129
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 24 (n=83, 82, 78, 74)	-0.06 x 10^3 c/µL	Standard Error 0.142
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 4 (n=92, 99, 90, 90)	0.17 x 10^3 c/µL	Standard Error 0.137
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 128 (n=30, 40, 40, 29)	0.22 x 10^3 c/µL	Standard Error 0.286
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 22 (n=77, 74, 76, 65)	0.45 x 10^3 c/µL	Standard Error 0.163
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 20 (n=83, 79, 78, 72)	0.02 x 10^3 c/µL	Standard Error 0.154
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 206 (n=17, 22, 23, 21)	0.38 x 10^3 c/µL	Standard Error 0.284
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 141 (n=28, 39, 34, 28)	0.51 x 10^3 c/µL	Standard Error 0.214
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 18 (n=78, 75, 82, 71)	0.32 x 10^3 c/µL	Standard Error 0.185
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 16 (n=90, 91, 83, 71)	0.19 x 10^3 c/µL	Standard Error 0.163
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 26, 23)	0.19 x 10^3 c/µL	Standard Error 0.157
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 154 (n=26, 34, 31, 24)	0.38 x 10^3 c/µL	Standard Error 0.217
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 14 (n=76, 78, 80, 75)	0.56 x 10^3 c/µL	Standard Error 0.192
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 12 (n=83, 88, 87, 82)	0.26 x 10^3 c/µL	Standard Error 0.163
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 2 (n=95, 99, 92, 86)	-0.23 x 10^3 c/µL	Standard Error 0.156
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 25)	0.35 x 10^3 c/µL	Standard Error 0.18
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 10 (n=68, 76, 69, 63)	0.53 x 10^3 c/µL	Standard Error 0.208
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 8 (n=91, 89, 90, 79)	0.16 x 10^3 c/µL	Standard Error 0.149
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Baseline (BL) (Week 0) (n=102, 106, 98, 94)	6.79 x 10^3 c/µL	Standard Error 0.182
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 89 (n=48, 58, 56, 42)	-0.18 x 10^3 c/µL	Standard Error 0.232
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 76 (n=51, 58, 63, 49)	-0.20 x 10^3 c/µL	Standard Error 0.169
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 63 (n=60, 66, 67, 55)	0.06 x 10^3 c/µL	Standard Error 0.176
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 26)	0.65 x 10^3 c/µL	Standard Error 0.267
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 102 (n=39, 47, 51, 40)	-0.09 x 10^3 c/µL	Standard Error 0.208
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 50 (n=67, 69, 71, 61)	0.29 x 10^3 c/µL	Standard Error 0.186
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 37 (n=74, 73, 70, 62)	0.14 x 10^3 c/µL	Standard Error 0.159
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 6 (n=89, 95, 87, 82)	0.09 x 10^3 c/µL	Standard Error 0.172
Placebo	Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 42, 34)	0.44 x 10^3 c/µL	Standard Error 0.286

Other Pre-specified

Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort

This cohort represents a different population (screening A1C \> 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort	49.09 years	Standard Deviation 8.63

Other Pre-specified

Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort

This cohort represents a different population (screening A1C \> 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort	31.73 kg/m^2	Standard Deviation 4.73

Other Pre-specified

Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort

This cohort represents a different population (screening A1C \> 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.

Time frame: Baseline

Arm	Measure	Group	Value (NUMBER)
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Age <65 years	64 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Age >=65 years	2 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Age >=75 years	0 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Gender, Male	32 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Gender, Female	34 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Age =<50 years, females only	19 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Age >50 years, females only	15 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Race, White	61 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Race, Black/African American	3 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Race, Asian	1 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Race, Other	1 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Ethnicity, Hispanic/Latino	13 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Ethnicity, Not Hispanic/Latino	37 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Ethnicity, Not Reported	16 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Body Mass Index <30%	22 participants
Saxagliptin 2.5 mg	Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort	Body Mass Index >=30%	44 participants

Other Pre-specified

Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort

This cohort represents a different population (screening A1C \> 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort	91.41 kg	Standard Deviation 20.65

Other Pre-specified

Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period

Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-0.0 mmHg	Standard Error 0.7
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-1.5 mmHg	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	0.4 mmHg	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-1.5 mmHg	Standard Error 0.8
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-1.7 mmHg	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-2.3 mmHg	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 50)	-0.8 mmHg	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	0.8 mmHg	Standard Error 2.3
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	0.8 mmHg	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-2.2 mmHg	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 102 (n=42, 51, 51, 42)	-1.1 mmHg	Standard Error 1.3
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-1.6 mmHg	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-1.3 mmHg	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-3.0 mmHg	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	-1.8 mmHg	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 69, 56)	-0.1 mmHg	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	1.2 mmHg	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-1.5 mmHg	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	1.4 mmHg	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-1.4 mmHg	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 66, 62)	-2.5 mmHg	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-1.4 mmHg	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-0.9 mmHg	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	0.3 mmHg	Standard Error 3.1
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	0.9 mmHg	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-0.4 mmHg	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-1.4 mmHg	Standard Error 0.7
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-1.7 mmHg	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	-3.7 mmHg	Standard Error 1.2
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	0.3 mmHg	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 69, 56)	-0.4 mmHg	Standard Error 1
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-2.7 mmHg	Standard Error 1.3
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-2.0 mmHg	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 50)	-1.1 mmHg	Standard Error 1.1
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-2.1 mmHg	Standard Error 1
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-1.1 mmHg	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 102 (n=42, 51, 51, 42)	-2.0 mmHg	Standard Error 1.2
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	-2.0 mmHg	Standard Error 2
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-2.0 mmHg	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-1.2 mmHg	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 66, 62)	-2.4 mmHg	Standard Error 1.1
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-0.5 mmHg	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	0.3 mmHg	Standard Error 1.4
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-1.6 mmHg	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-0.9 mmHg	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-1.8 mmHg	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	-0.6 mmHg	Standard Error 2.4
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	-0.8 mmHg	Standard Error 1.3
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-2.0 mmHg	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	-1.6 mmHg	Standard Error 2
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-1.7 mmHg	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	-2.0 mmHg	Standard Error 1.5
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-2.2 mmHg	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-0.9 mmHg	Standard Error 0.8
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	2.4 mmHg	Standard Error 1.8
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-0.5 mmHg	Standard Error 0.7
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	0.3 mmHg	Standard Error 0.8
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-0.8 mmHg	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-0.7 mmHg	Standard Error 0.8
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 50)	-1.3 mmHg	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-0.7 mmHg	Standard Error 0.8
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 66, 62)	-2.4 mmHg	Standard Error 1
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-0.1 mmHg	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-1.9 mmHg	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-1.9 mmHg	Standard Error 1
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-2.5 mmHg	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-2.3 mmHg	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-0.3 mmHg	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-0.6 mmHg	Standard Error 1
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-0.3 mmHg	Standard Error 1
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 69, 56)	-0.0 mmHg	Standard Error 1
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	0.1 mmHg	Standard Error 1.1
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-1.6 mmHg	Standard Error 1.2
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 102 (n=42, 51, 51, 42)	-0.4 mmHg	Standard Error 1.2
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-1.1 mmHg	Standard Error 1.1
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	1.1 mmHg	Standard Error 1.3
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	1.1 mmHg	Standard Error 1.7
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	2.5 mmHg	Standard Error 1.5
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	0.5 mmHg	Standard Error 1.7
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	0.5 mmHg	Standard Error 1.7
Saxagliptin 10 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	1.9 mmHg	Standard Error 1.6
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-2.0 mmHg	Standard Error 1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	-0.2 mmHg	Standard Error 2.4
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	1.0 mmHg	Standard Error 1.6
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-2.8 mmHg	Standard Error 1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-3.4 mmHg	Standard Error 1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	-0.2 mmHg	Standard Error 2.3
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	1.3 mmHg	Standard Error 1.8
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-1.7 mmHg	Standard Error 1.1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-2.2 mmHg	Standard Error 1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-1.8 mmHg	Standard Error 0.8
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	1.3 mmHg	Standard Error 1.8
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-2.1 mmHg	Standard Error 1.1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-2.1 mmHg	Standard Error 1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 66, 62)	-2.7 mmHg	Standard Error 1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	-1.1 mmHg	Standard Error 1.8
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-1.8 mmHg	Standard Error 1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 50)	-3.4 mmHg	Standard Error 1.1
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-1.5 mmHg	Standard Error 0.9
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	-0.8 mmHg	Standard Error 1.9
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-0.1 mmHg	Standard Error 1.4
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-2.4 mmHg	Standard Error 0.8
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 102 (n=42, 51, 51, 42)	-1.2 mmHg	Standard Error 1.2
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-0.3 mmHg	Standard Error 1.4
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 63 (n=61, 66, 69, 56)	-0.5 mmHg	Standard Error 1.2
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-1.9 mmHg	Standard Error 0.9
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-1.0 mmHg	Standard Error 1.5
Placebo	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-0.6 mmHg	Standard Error 1.1

Other Pre-specified

Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort

Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 2 (n=62)	-3.7 mmHg	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 4 (n=59)	-1.7 mmHg	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 6 (n=60)	-2.8 mmHg	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 8 (n=49)	-2.0 mmHg	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 10 (n=24)	-1.0 mmHg	Standard Error 2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 12 (n=47)	-3.7 mmHg	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 14 (n=35)	-4.5 mmHg	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 16 (n=46)	-2.8 mmHg	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 18 (n=42)	-3.3 mmHg	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 20 (n=45)	-2.1 mmHg	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 22 (n=44)	-2.8 mmHg	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 24 (n=44)	-3.4 mmHg	Standard Error 1.3
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 30 (n=40)	-3.8 mmHg	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 37 (n=35)	-2.0 mmHg	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 50 (n=36)	-1.3 mmHg	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 63 (n=26)	-0.9 mmHg	Standard Error 1.8
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 76 (n=24)	-1.0 mmHg	Standard Error 2
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 89 (n=23)	-2.6 mmHg	Standard Error 1.9
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 102 (n=15)	1.0 mmHg	Standard Error 3
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 115 (n=13)	-4.1 mmHg	Standard Error 2.5
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 128 (n=11)	-3.7 mmHg	Standard Error 2.8
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 141 (n=10)	-6.0 mmHg	Standard Error 2.6
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 154 (n=10)	-0.5 mmHg	Standard Error 2.7
Saxagliptin 2.5 mg	Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 167 (n=10)	-2.5 mmHg	Standard Error 2.9

Other Pre-specified

Changes From Baseline in Heart Rate During the ST + LT Period

Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-0.1 beats per minute	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-0.4 beats per minute	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-0.8 beats per minute	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	-5.1 beats per minute	Standard Error 1.9
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-0.1 beats per minute	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-0.3 beats per minute	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-0.0 beats per minute	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-1.5 beats per minute	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	0.1 beats per minute	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	1.3 beats per minute	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	-4.6 beats per minute	Standard Error 2.4
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	-2.0 beats per minute	Standard Error 2.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	-2.8 beats per minute	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-0.5 beats per minute	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	-3.1 beats per minute	Standard Error 2.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	-2.1 beats per minute	Standard Error 1.8
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-3.2 beats per minute	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 49)	-0.2 beats per minute	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	0.2 beats per minute	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 102 (n=42, 51, 51, 42)	-2.8 beats per minute	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-0.5 beats per minute	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	0.3 beats per minute	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-0.1 beats per minute	Standard Error 0.9
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-0.3 beats per minute	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 63 (n=62, 66, 69, 56)	-0.4 beats per minute	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 65, 62)	0.1 beats per minute	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	-5.3 beats per minute	Standard Error 2.6
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	-0.8 beats per minute	Standard Error 1.4
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-0.5 beats per minute	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-1.1 beats per minute	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-0.6 beats per minute	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-0.9 beats per minute	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 49)	-1.5 beats per minute	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-1.2 beats per minute	Standard Error 0.8
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 65, 62)	-0.5 beats per minute	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-1.5 beats per minute	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-0.8 beats per minute	Standard Error 1.1
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-1.5 beats per minute	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-0.3 beats per minute	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	0.1 beats per minute	Standard Error 1.1
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-1.2 beats per minute	Standard Error 1.1
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-1.4 beats per minute	Standard Error 0.9
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-0.7 beats per minute	Standard Error 1.1
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 63 (n=62, 66, 69, 56)	-2.5 beats per minute	Standard Error 1
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-3.3 beats per minute	Standard Error 1.1
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-1.5 beats per minute	Standard Error 1.2
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 102 (n=42, 51, 51, 42)	-1.5 beats per minute	Standard Error 1.4
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-2.3 beats per minute	Standard Error 1.3
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	-4.5 beats per minute	Standard Error 1.6
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	-3.5 beats per minute	Standard Error 1.5
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	-2.6 beats per minute	Standard Error 1.6
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	-5.3 beats per minute	Standard Error 1.8
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	-4.2 beats per minute	Standard Error 1.8
Saxagliptin 5 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	-2.6 beats per minute	Standard Error 1.9
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	1.5 beats per minute	Standard Error 1
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	0.5 beats per minute	Standard Error 1
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 65, 62)	0.6 beats per minute	Standard Error 1.1
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-0.2 beats per minute	Standard Error 1
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 63 (n=62, 66, 69, 56)	0.9 beats per minute	Standard Error 1.1
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	0.5 beats per minute	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	0.4 beats per minute	Standard Error 1.1
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	-2.0 beats per minute	Standard Error 2
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-0.9 beats per minute	Standard Error 1.1
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 49)	-1.0 beats per minute	Standard Error 1.2
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 102 (n=42, 51, 51, 42)	-0.1 beats per minute	Standard Error 1.4
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	0.2 beats per minute	Standard Error 0.8
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	1.0 beats per minute	Standard Error 1.6
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	0.2 beats per minute	Standard Error 0.8
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	0.0 beats per minute	Standard Error 2.7
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	-0.7 beats per minute	Standard Error 1.4
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	-2.4 beats per minute	Standard Error 2
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	-0.6 beats per minute	Standard Error 1.6
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-0.6 beats per minute	Standard Error 0.8
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	-1.3 beats per minute	Standard Error 1.8
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	1.3 beats per minute	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	-2.1 beats per minute	Standard Error 2.4
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	0.9 beats per minute	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-0.7 beats per minute	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-0.1 beats per minute	Standard Error 0.9
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	0.7 beats per minute	Standard Error 0.7
Saxagliptin 10 mg	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-0.7 beats per minute	Standard Error 0.8
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	0.8 beats per minute	Standard Error 1.1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-0.4 beats per minute	Standard Error 1.1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-0.9 beats per minute	Standard Error 1.2
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	-0.6 beats per minute	Standard Error 2
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	0.5 beats per minute	Standard Error 1.6
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	1.7 beats per minute	Standard Error 1.8
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-0.2 beats per minute	Standard Error 1.2
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	0.8 beats per minute	Standard Error 1.1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	0.3 beats per minute	Standard Error 0.9
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	1.4 beats per minute	Standard Error 1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 63 (n=62, 66, 69, 56)	0.6 beats per minute	Standard Error 1.4
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 65, 62)	1.9 beats per minute	Standard Error 1.1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	-0.8 beats per minute	Standard Error 2.1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	1.5 beats per minute	Standard Error 1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	0.2 beats per minute	Standard Error 1.6
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 49)	0.1 beats per minute	Standard Error 1.3
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	0.9 beats per minute	Standard Error 1.7
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-0.1 beats per minute	Standard Error 1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-0.3 beats per minute	Standard Error 1.3
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	1.1 beats per minute	Standard Error 2.1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	-1.2 beats per minute	Standard Error 1.4
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	2.6 beats per minute	Standard Error 1
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 102 (n=42, 51, 51, 42)	-0.0 beats per minute	Standard Error 1.6
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-0.2 beats per minute	Standard Error 0.9
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-0.1 beats per minute	Standard Error 0.9
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-1.2 beats per minute	Standard Error 1.3
Placebo	Changes From Baseline in Heart Rate During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	0.8 beats per minute	Standard Error 1.9

Other Pre-specified

Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort

Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 2 (n=62)	-0.8 beats per minute	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 4 (n=59)	-0.4 beats per minute	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 6 (n=60)	-0.3 beats per minute	Standard Error 1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 8 (n=49)	-0.7 beats per minute	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 10 (n=23)	-1.8 beats per minute	Standard Error 2.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 12 (n=47)	-3.0 beats per minute	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 14 (n=34)	-2.0 beats per minute	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 16 (n=46)	-0.7 beats per minute	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 18 (n=42)	-2.0 beats per minute	Standard Error 1.3
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 20 (n=45)	1.6 beats per minute	Standard Error 1.1
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 22 (n=43)	-0.4 beats per minute	Standard Error 1.2
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 24 (n=44)	-0.4 beats per minute	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 30 (n=40)	0.6 beats per minute	Standard Error 1.3
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 37 (n=35)	-1.6 beats per minute	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 50 (n=36)	-2.9 beats per minute	Standard Error 1.3
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 63 (n=26)	-3.0 beats per minute	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 76 (n=24)	-0.4 beats per minute	Standard Error 2.5
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 89 (n=23)	-1.3 beats per minute	Standard Error 1.8
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 102 (n=15)	-0.3 beats per minute	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 115 (n=13)	1.7 beats per minute	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 128 (n=11)	-1.6 beats per minute	Standard Error 3.6
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 141 (n=10)	-3.4 beats per minute	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 154 (n=10)	-1.5 beats per minute	Standard Error 2.6
Saxagliptin 2.5 mg	Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort	Change from BL at Week 167 (n=10)	-1.9 beats per minute	Standard Error 3.3

Other Pre-specified

Changes From Baseline in Systolic Blood Pressure During the ST + LT Period

Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-1.0 mmHg	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-3.2 mmHg	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-2.8 mmHg	Standard Error 2
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-1.5 mmHg	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-2.5 mmHg	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-5.1 mmHg	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 50)	-3.6 mmHg	Standard Error 2
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	3.4 mmHg	Standard Error 4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	0.7 mmHg	Standard Error 2.9
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-5.0 mmHg	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 102 (n=42, 47, 50, 40)	-0.6 mmHg	Standard Error 2.1
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-2.9 mmHg	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-3.3 mmHg	Standard Error 1.3
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-6.1 mmHg	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	-5.1 mmHg	Standard Error 2.5
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 63 (n=62, 66, 69, 56)	-1.2 mmHg	Standard Error 1.9
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	-0.8 mmHg	Standard Error 2.8
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-2.8 mmHg	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	0.9 mmHg	Standard Error 2.9
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-3.0 mmHg	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 66, 62)	-4.9 mmHg	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-3.6 mmHg	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-2.6 mmHg	Standard Error 2.4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	4.8 mmHg	Standard Error 5
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	-1.8 mmHg	Standard Error 3
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-3.0 mmHg	Standard Error 1.7
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-1.9 mmHg	Standard Error 1.4
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-3.5 mmHg	Standard Error 1.4
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	-5.5 mmHg	Standard Error 1.9
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	0.1 mmHg	Standard Error 1.4
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 63 (n=62, 66, 69, 56)	-0.3 mmHg	Standard Error 1.4
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-2.6 mmHg	Standard Error 2
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-2.6 mmHg	Standard Error 1.6
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 50)	-2.9 mmHg	Standard Error 1.5
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-3.4 mmHg	Standard Error 1.4
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-1.2 mmHg	Standard Error 1.1
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 102 (n=42, 47, 50, 40)	-1.1 mmHg	Standard Error 1.9
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	-5.4 mmHg	Standard Error 3.2
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-2.9 mmHg	Standard Error 1.2
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-2.0 mmHg	Standard Error 1.3
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 66, 62)	-2.0 mmHg	Standard Error 1.5
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-2.1 mmHg	Standard Error 1.3
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	-1.8 mmHg	Standard Error 2.5
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-0.9 mmHg	Standard Error 1.5
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-2.1 mmHg	Standard Error 1.2
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-3.2 mmHg	Standard Error 1.3
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	-2.8 mmHg	Standard Error 3.3
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	-0.5 mmHg	Standard Error 2.3
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-4.5 mmHg	Standard Error 1.3
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	-7.5 mmHg	Standard Error 3.2
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-4.1 mmHg	Standard Error 1.2
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	-5.2 mmHg	Standard Error 2.3
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-3.8 mmHg	Standard Error 1.5
Saxagliptin 5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-1.8 mmHg	Standard Error 1.2
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	4.0 mmHg	Standard Error 2.5
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-2.3 mmHg	Standard Error 1.2
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-2.3 mmHg	Standard Error 1.1
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-3.5 mmHg	Standard Error 1.3
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-4.0 mmHg	Standard Error 1.2
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 50)	-5.0 mmHg	Standard Error 1.5
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-2.8 mmHg	Standard Error 1.3
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 66, 62)	-6.0 mmHg	Standard Error 1.7
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-3.8 mmHg	Standard Error 1.4
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-4.3 mmHg	Standard Error 1.7
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-3.3 mmHg	Standard Error 1.4
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-5.9 mmHg	Standard Error 1.5
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-6.2 mmHg	Standard Error 1.5
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-3.9 mmHg	Standard Error 1.5
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-5.2 mmHg	Standard Error 1.5
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-3.3 mmHg	Standard Error 1.5
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 63 (n=62, 66, 69, 56)	-1.1 mmHg	Standard Error 1.5
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-3.1 mmHg	Standard Error 1.8
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-5.4 mmHg	Standard Error 2
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 102 (n=42, 47, 50, 40)	-2.9 mmHg	Standard Error 2.1
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	-1.6 mmHg	Standard Error 1.9
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	0.0 mmHg	Standard Error 1.9
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	0.3 mmHg	Standard Error 2.6
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	3.5 mmHg	Standard Error 2.6
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	0.9 mmHg	Standard Error 2.4
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	0.0 mmHg	Standard Error 3
Saxagliptin 10 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	2.3 mmHg	Standard Error 2.6
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 37 (n=77, 74, 71, 66)	-3.6 mmHg	Standard Error 1.7
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 206 (n=17, 24, 24, 23)	0.7 mmHg	Standard Error 4
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 128 (n=31, 40, 41, 31)	1.1 mmHg	Standard Error 2.7
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 30 (n=79, 78, 79, 66)	-5.4 mmHg	Standard Error 1.9
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 24 (n=84, 83, 77, 75)	-6.3 mmHg	Standard Error 1.7
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 193 (n=19, 26, 27, 24)	-2.6 mmHg	Standard Error 3.6
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 141 (n=29, 40, 35, 29)	-1.4 mmHg	Standard Error 3.1
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 22 (n=78, 73, 76, 64)	-3.9 mmHg	Standard Error 1.9
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 20 (n=84, 80, 76, 73)	-4.9 mmHg	Standard Error 1.7
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 4 (n=96, 100, 92, 91)	-4.3 mmHg	Standard Error 1.4
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 154 (n=27, 36, 33, 27)	2.3 mmHg	Standard Error 3.1
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 18 (n=73, 69, 76, 66)	-4.7 mmHg	Standard Error 1.9
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 16 (n=87, 87, 81, 72)	-2.1 mmHg	Standard Error 1.5
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 14 (n=65, 72, 66, 62)	-1.9 mmHg	Standard Error 1.6
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 167 (n=24, 33, 30, 27)	-0.6 mmHg	Standard Error 3.1
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 12 (n=82, 83, 87, 79)	-3.2 mmHg	Standard Error 1.6
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 10 (n=51, 66, 51, 50)	-6.1 mmHg	Standard Error 1.7
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 2 (n=96, 100, 94, 89)	-3.1 mmHg	Standard Error 1.4
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 180 (n=21, 28, 28, 27)	-0.8 mmHg	Standard Error 2.6
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 89 (n=49, 58, 56, 44)	-2.2 mmHg	Standard Error 2.2
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 8 (n=94, 91, 91, 80)	-5.5 mmHg	Standard Error 1.5
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 102 (n=42, 47, 50, 40)	-1.0 mmHg	Standard Error 2.5
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 76 (n=53, 59, 64, 50)	-0.9 mmHg	Standard Error 2.2
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 63 (n=62, 66, 69, 56)	-2.4 mmHg	Standard Error 2.1
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 6 (n=91, 98, 88, 84)	-4.5 mmHg	Standard Error 1.4
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 115 (n=34, 43, 43, 37)	0.9 mmHg	Standard Error 2.7
Placebo	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period	Change from BL at Week 50 (n=70, 73, 73, 62)	-0.4 mmHg	Standard Error 1.9

Other Pre-specified

Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort

Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167

Population: Treated participants; n=number of treated participants with measurement at time point

Arm	Measure	Group	Value (MEAN)	Dispersion
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 2 (n=62)	-4.4 mmHg	Standard Error 1.3
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 4 (n=59)	-3.8 mmHg	Standard Error 1.4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 6 (n=60)	-2.7 mmHg	Standard Error 1.5
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 8 (n=49)	-5.1 mmHg	Standard Error 1.6
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 10 (n=24)	-4.2 mmHg	Standard Error 2.8
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 12 (n=47)	-4.9 mmHg	Standard Error 1.8
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 14 (n=35)	-5.1 mmHg	Standard Error 2
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 16 (n=46)	-1.9 mmHg	Standard Error 2.2
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 18 (n=42)	-5.8 mmHg	Standard Error 2
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 20 (n=45)	-3.6 mmHg	Standard Error 2
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 22 (n=44)	-4.0 mmHg	Standard Error 2.1
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 24 (n=44)	-4.3 mmHg	Standard Error 2.1
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 30 (n=40)	-4.8 mmHg	Standard Error 1.8
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 37 (n=35)	-4.7 mmHg	Standard Error 1.8
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 50 (n=36)	-1.6 mmHg	Standard Error 2.1
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 63 (n=26)	-0.7 mmHg	Standard Error 2.7
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 76 (n=24)	-1.9 mmHg	Standard Error 2.1
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 89 (n=23)	-4.0 mmHg	Standard Error 2.6
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 102 (n=15)	0.9 mmHg	Standard Error 2.4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 115 (n=13)	-6.6 mmHg	Standard Error 3.6
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 128 (n=11)	-5.6 mmHg	Standard Error 4.3
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 141 (n=10)	-7.2 mmHg	Standard Error 4.4
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 154 (n=10)	5.7 mmHg	Standard Error 4.7
Saxagliptin 2.5 mg	Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort	Change from BL at Week 167 (n=10)	-2.2 mmHg	Standard Error 4.4

Other Pre-specified

Confirmed Hypoglycemia During ST + LT Treatment Period

'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose \<= 50 mg/dL and associated symptoms

Population: Treated participants

Arm	Measure	Value (NUMBER)
Saxagliptin 2.5 mg	Confirmed Hypoglycemia During ST + LT Treatment Period	1 participants
Saxagliptin 5 mg	Confirmed Hypoglycemia During ST + LT Treatment Period	1 participants
Saxagliptin 10 mg	Confirmed Hypoglycemia During ST + LT Treatment Period	0 participants
Placebo	Confirmed Hypoglycemia During ST + LT Treatment Period	0 participants

Other Pre-specified

Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort

'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose \<= 50 mg/dL and associated symptoms

Time frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.

Population: Treated participants

Arm	Measure	Value (NUMBER)
Saxagliptin 2.5 mg	Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort	0 participants

Other Pre-specified

Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period

The normality/abnormality of the ECG tracing was determined by the investigator.

Time frame: Baseline, Weeks 12, 24, 76, 102, 154, 206

Population: Treated participants; BL n=number of participants at baseline

Arm	Measure	Group	Value (NUMBER)
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 24 (BL n=53, 52, 47, 33)	43 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 154 (BL n=7, 16, 11, 13)	4 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 154(BL n=7, 16, 11, 13)	3 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 206 (BL n=15, 13, 20, 14)	15 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 12 (BL n=65, 66, 67, 47)	8 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 206 (BL n=15, 13, 20, 14)	0 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 24 (BL n=53, 52, 47, 33)	10 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 206 (BL n=4, 13, 8, 11)	2 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 24 (BL n=19, 24, 21, 25)	5 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 24(BL n=19, 24, 21, 25)	14 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 76 (BL n=48, 49, 48, 36)	37 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 12 (BL n=27, 32, 26, 43)	6 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 76 (BL n=48, 49, 48, 36)	11 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 76 (BL n=19, 23, 21, 27)	8 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 76(BL n=19, 23, 21, 27)	11 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 102 (BL n=32, 32, 36, 22)	25 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 12(BL n=27, 32, 26, 43)	21 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 102 (BL n=32, 32, 36, 22)	7 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 102 (BL n=12, 18, 17, 20)	4 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 206 (BL n=4, 13, 8, 11)	2 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL,Abnormal Week 102(BL n=12, 18, 17, 20)	8 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 154 (BL n=20, 21, 26, 15)	16 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 12 (BL n=65, 66, 67, 47)	57 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 154 (BL n=20, 21, 26, 15)	4 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 12 (BL n=65, 66, 67, 47)	10 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 12(BL n=27, 32, 26, 43)	26 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 24 (BL n=19, 24, 21, 25)	8 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 154 (BL n=20, 21, 26, 15)	17 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 24(BL n=19, 24, 21, 25)	16 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 12 (BL n=65, 66, 67, 47)	56 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 102 (BL n=12, 18, 17, 20)	5 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 76 (BL n=48, 49, 48, 36)	44 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 76 (BL n=48, 49, 48, 36)	5 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 12 (BL n=27, 32, 26, 43)	6 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 154 (BL n=20, 21, 26, 15)	4 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 76 (BL n=19, 23, 21, 27)	8 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL,Abnormal Week 102(BL n=12, 18, 17, 20)	13 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 76(BL n=19, 23, 21, 27)	15 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 154 (BL n=7, 16, 11, 13)	4 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 24 (BL n=53, 52, 47, 33)	44 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 102 (BL n=32, 32, 36, 22)	26 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 154(BL n=7, 16, 11, 13)	12 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 206 (BL n=15, 13, 20, 14)	12 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 206 (BL n=15, 13, 20, 14)	1 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 102 (BL n=32, 32, 36, 22)	6 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 206 (BL n=4, 13, 8, 11)	3 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 24 (BL n=53, 52, 47, 33)	8 participants
Saxagliptin 5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 206 (BL n=4, 13, 8, 11)	10 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 12 (BL n=65, 66, 67, 47)	59 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL,Abnormal Week 102(BL n=12, 18, 17, 20)	5 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 206 (BL n=4, 13, 8, 11)	4 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 24 (BL n=19, 24, 21, 25)	9 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 12 (BL n=65, 66, 67, 47)	8 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 154 (BL n=7, 16, 11, 13)	5 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 206 (BL n=15, 13, 20, 14)	2 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 24(BL n=19, 24, 21, 25)	12 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 102 (BL n=32, 32, 36, 22)	5 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 24 (BL n=53, 52, 47, 33)	4 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 154(BL n=7, 16, 11, 13)	6 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 76 (BL n=48, 49, 48, 36)	40 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 102 (BL n=12, 18, 17, 20)	12 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 154 (BL n=20, 21, 26, 15)	23 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 24 (BL n=53, 52, 47, 33)	43 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 76 (BL n=48, 49, 48, 36)	8 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 102 (BL n=32, 32, 36, 22)	31 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 206 (BL n=4, 13, 8, 11)	4 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 206 (BL n=15, 13, 20, 14)	18 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 76 (BL n=19, 23, 21, 27)	6 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 12 (BL n=27, 32, 26, 43)	9 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 12(BL n=27, 32, 26, 43)	17 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 154 (BL n=20, 21, 26, 15)	3 participants
Saxagliptin 10 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 76(BL n=19, 23, 21, 27)	15 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 102 (BL n=12, 18, 17, 20)	11 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 12 (BL n=65, 66, 67, 47)	43 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 12 (BL n=65, 66, 67, 47)	4 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 12 (BL n=27, 32, 26, 43)	15 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 12(BL n=27, 32, 26, 43)	28 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 24 (BL n=53, 52, 47, 33)	31 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 24 (BL n=53, 52, 47, 33)	2 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 24 (BL n=19, 24, 21, 25)	8 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 24(BL n=19, 24, 21, 25)	17 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 76 (BL n=48, 49, 48, 36)	30 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 76 (BL n=48, 49, 48, 36)	6 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 76 (BL n=19, 23, 21, 27)	13 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 76(BL n=19, 23, 21, 27)	14 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 102 (BL n=32, 32, 36, 22)	18 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 102 (BL n=32, 32, 36, 22)	4 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL,Abnormal Week 102(BL n=12, 18, 17, 20)	9 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 154 (BL n=20, 21, 26, 15)	14 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 154 (BL n=20, 21, 26, 15)	1 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 154 (BL n=7, 16, 11, 13)	7 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 154(BL n=7, 16, 11, 13)	6 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Normal Week 206 (BL n=15, 13, 20, 14)	11 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Normal BL, Abnormal Week 206 (BL n=15, 13, 20, 14)	3 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Normal Week 206 (BL n=4, 13, 8, 11)	4 participants
Placebo	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period	Abnormal BL, Abnormal Week 206 (BL n=4, 13, 8, 11)	7 participants

Other Pre-specified

Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort

The normality/abnormality of the ECG tracing was determined by the investigator.

Time frame: Baseline, Weeks 12, 24, 76, 102, 154, 206

Population: Treated participants; BL n=number of participants at baseline

Arm	Measure	Group	Value (NUMBER)
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Normal Week 12 (BL n=23)	19 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Abnormal Week 12 (BL n=23)	4 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Normal Week 12 (BL n=18)	5 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Abnormal Week 12 (BL n=18)	13 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Normal Week 24 (BL n=10)	8 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Abnormal Week 24 (BL n=10)	2 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Normal Week 24 (BL n=6)	2 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Abnormal Week 24(BL n=6)	4 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Normal Week 76 (BL n=17)	13 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Abnormal Week 76 (BL n=17)	4 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Normal Week 76 (BL n=13)	4 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Abnormal Week 76 (BL n=13)	9 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Normal Week 102 (BL n=8)	6 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Abnormal Week 102 (BL n=8)	2 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Normal Week 102 (BL n=4)	1 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Abnormal Week 102 (BL n=4)	3 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Normal Week 154 (BL n=4)	3 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Abnormal Week 154 (BL n=4)	1 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Normal Week 154 (BL n=2)	0 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Abnormal Week 154 (BL n=2)	2 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Normal Week 206 (BL n=3)	2 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Normal BL, Abnormal Week 206 (BL n=3)	1 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Normal Week 206 (BL n=1)	0 participants
Saxagliptin 2.5 mg	Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort	Abnormal BL, Abnormal Week 206 (BL n=1)	1 participants

Other Pre-specified

Marked Laboratory Abnormalities - During ST + LT Treatment Period

A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: \<0.9 x Pre-Rx & \<=130mEq/L / high: \>1.1 x Pre-Rx & \>=150mEq/L; potassium, serum low: \<=0.8 x Pre-Rx & \>=6.0mEq/L / high: 1.2 x Pre-Rx & \>=6.0mEq/L; LLN=lower limit of normal.

Time frame: Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.

Population: Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period

Arm	Measure	Group	Value (NUMBER)
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Potassium,Serum Low(see above)(n=101, 105, 97, 94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Blood Urine, >=2-4 (n=99, 103, 94, 92)	5 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Eosinophils >0.9x1000 c/µL (n=101, 105, 97, 93)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Sodium,Serum High(see above) (n=101, 105, 97, 94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	White Blood Cells Urine >=2-4 (n=95, 97, 89, 88)	13 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Sodium,Serum Low (see above) (n=101, 105, 97, 94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Plasma Fasting<50mg/dL(n=101, 104, 96,94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Hemoglobin < 8 g/dL (n=101, 105, 97, 93)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose,Plasma Unspec.>500mg/dL(n=102, 105, 98,95)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose,Plasma Fasting>500mg/dL(n=101, 104, 96,94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Lymphocytes <=0.75x1000 c/µL (n=101, 105, 97, 93)	4 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Plasma Unspec.<50mg/dL(n=102, 105, 98,95)	7 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Platelets < 50 x 10^9 c/L (n=100, 104, 94, 93)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Protein Urine, >=2-4 (n=99, 103, 94, 92)	8 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALP >3 x pre-Rx and >ULN (n=101,105, 97, 94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALP >1.5 x ULN (n=101, 105, 97, 94)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Uric Acid > 1.5 x ULN (n=0, 0, 0, 0)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >3 x ULN (n=101, 105, 97, 94)	3 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >5 x ULN (n=101, 105, 97, 94)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Platelets > 1.5 x ULN (n=100,104, 94, 93)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Creatine Kinase > 5 x ULN (n=101, 105, 97, 94)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >10 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >20 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Hematocrit < 0.75 x pre-Rx (n=101, 105, 97, 93)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Albumin < 0.9 LLN (n=101, 105, 97, 94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >3 x ULN (n=101, 105, 97, 94)	3 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Red Blood Cells Urine >=2-4 (n=95, 97, 89, 88)	6 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >5 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Leukocytes < 2 x 1000 c/µL (n=101, 105, 97, 93)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Chloride > 120 mEq/L (n=101, 105, 97, 94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >10 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >20 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Chloride < 90 mEq/L (n=101, 105, 97, 94)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >2mg/dL (n=101, 105, 97, 94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >1.5xULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Neutrophils+Bands <1x1000 c/µL(n=101, 105, 97, 93)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Potassium, Serum High(see above)(n=101,105,97,94)	3 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >2xULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	BUN >2 x pre-Rx and >ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Creatinine >2.5 mg/dL (n=101, 105, 97, 94)	1 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Leukocytes < 2 x 1000 c/µL (n=101, 105, 97, 93)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Creatinine >2.5 mg/dL (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >5 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Sodium,Serum High(see above) (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Chloride < 90 mEq/L (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Hemoglobin < 8 g/dL (n=101, 105, 97, 93)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >20 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >10 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Eosinophils >0.9x1000 c/µL (n=101, 105, 97, 93)	5 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Sodium,Serum Low (see above) (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Platelets > 1.5 x ULN (n=100,104, 94, 93)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Albumin < 0.9 LLN (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Hematocrit < 0.75 x pre-Rx (n=101, 105, 97, 93)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >20 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Protein Urine, >=2-4 (n=99, 103, 94, 92)	9 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose,Plasma Unspec.>500mg/dL(n=102, 105, 98,95)	1 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	BUN >2 x pre-Rx and >ULN (n=101, 105, 97, 94)	3 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Plasma Fasting<50mg/dL(n=101, 104, 96,94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >2xULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >2mg/dL (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >3 x ULN (n=101, 105, 97, 94)	2 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose,Plasma Fasting>500mg/dL(n=101, 104, 96,94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Blood Urine, >=2-4 (n=99, 103, 94, 92)	11 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Plasma Unspec.<50mg/dL(n=102, 105, 98,95)	4 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Chloride > 120 mEq/L (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Lymphocytes <=0.75x1000 c/µL (n=101, 105, 97, 93)	2 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Potassium, Serum High(see above)(n=101,105,97,94)	3 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >5 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Neutrophils+Bands <1x1000 c/µL(n=101, 105, 97, 93)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALP >3 x pre-Rx and >ULN (n=101,105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Platelets < 50 x 10^9 c/L (n=100, 104, 94, 93)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Uric Acid > 1.5 x ULN (n=0, 0, 0, 0)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >1.5xULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALP >1.5 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	White Blood Cells Urine >=2-4 (n=95, 97, 89, 88)	19 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Potassium,Serum Low(see above)(n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >10 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >3 x ULN (n=101, 105, 97, 94)	2 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Red Blood Cells Urine >=2-4 (n=95, 97, 89, 88)	8 participants
Saxagliptin 5 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Creatine Kinase > 5 x ULN (n=101, 105, 97, 94)	4 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Plasma Fasting<50mg/dL(n=101, 104, 96,94)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Hemoglobin < 8 g/dL (n=101, 105, 97, 93)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Hematocrit < 0.75 x pre-Rx (n=101, 105, 97, 93)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Platelets < 50 x 10^9 c/L (n=100, 104, 94, 93)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Platelets > 1.5 x ULN (n=100,104, 94, 93)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Leukocytes < 2 x 1000 c/µL (n=101, 105, 97, 93)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Neutrophils+Bands <1x1000 c/µL(n=101, 105, 97, 93)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Eosinophils >0.9x1000 c/µL (n=101, 105, 97, 93)	3 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Lymphocytes <=0.75x1000 c/µL (n=101, 105, 97, 93)	2 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALP >3 x pre-Rx and >ULN (n=101,105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALP >1.5 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >3 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >5 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >10 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >20 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >3 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >5 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >10 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >20 x ULN (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >2mg/dL (n=101, 105, 97, 94)	3 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >1.5xULN (n=101, 105, 97, 94)	3 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >2xULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	BUN >2 x pre-Rx and >ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Creatinine >2.5 mg/dL (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose,Plasma Fasting>500mg/dL(n=101, 104, 96,94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Plasma Unspec.<50mg/dL(n=102, 105, 98,95)	4 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose,Plasma Unspec.>500mg/dL(n=102, 105, 98,95)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Sodium,Serum Low (see above) (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Sodium,Serum High(see above) (n=101, 105, 97, 94)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Potassium,Serum Low(see above)(n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Potassium, Serum High(see above)(n=101,105,97,94)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Chloride < 90 mEq/L (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Chloride > 120 mEq/L (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Albumin < 0.9 LLN (n=101, 105, 97, 94)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Creatine Kinase > 5 x ULN (n=101, 105, 97, 94)	1 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Uric Acid > 1.5 x ULN (n=0, 0, 0, 0)	0 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Protein Urine, >=2-4 (n=99, 103, 94, 92)	4 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Blood Urine, >=2-4 (n=99, 103, 94, 92)	8 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Red Blood Cells Urine >=2-4 (n=95, 97, 89, 88)	8 participants
Saxagliptin 10 mg	Marked Laboratory Abnormalities - During ST + LT Treatment Period	White Blood Cells Urine >=2-4 (n=95, 97, 89, 88)	15 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	BUN >2 x pre-Rx and >ULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >2xULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Leukocytes < 2 x 1000 c/µL (n=101, 105, 97, 93)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Potassium,Serum Low(see above)(n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >1.5xULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Bilirubin Total >2mg/dL (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Hemoglobin < 8 g/dL (n=101, 105, 97, 93)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Potassium, Serum High(see above)(n=101,105,97,94)	3 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >20 x ULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >10 x ULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Blood Urine, >=2-4 (n=99, 103, 94, 92)	16 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Chloride < 90 mEq/L (n=101, 105, 97, 94)	1 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >5 x ULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALT >3 x ULN (n=101, 105, 97, 94)	1 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Platelets > 1.5 x ULN (n=100,104, 94, 93)	1 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Chloride > 120 mEq/L (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >20 x ULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >10 x ULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Platelets < 50 x 10^9 c/L (n=100, 104, 94, 93)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Albumin < 0.9 LLN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >5 x ULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	AST >3 x ULN (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	White Blood Cells Urine >=2-4 (n=95, 97, 89, 88)	12 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Creatine Kinase > 5 x ULN (n=101, 105, 97, 94)	4 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALP >1.5 x ULN (n=101, 105, 97, 94)	1 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	ALP >3 x pre-Rx and >ULN (n=101,105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Red Blood Cells Urine >=2-4 (n=95, 97, 89, 88)	14 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Uric Acid > 1.5 x ULN (n=0, 0, 0, 0)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Lymphocytes <=0.75x1000 c/µL (n=101, 105, 97, 93)	1 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose,Plasma Fasting>500mg/dL(n=101, 104, 96,94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Eosinophils >0.9x1000 c/µL (n=101, 105, 97, 93)	4 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Plasma Unspec.<50mg/dL(n=102, 105, 98,95)	3 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Plasma Fasting<50mg/dL(n=101, 104, 96,94)	2 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Hematocrit < 0.75 x pre-Rx (n=101, 105, 97, 93)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose,Plasma Unspec.>500mg/dL(n=102, 105, 98,95)	2 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Protein Urine, >=2-4 (n=99, 103, 94, 92)	3 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Sodium,Serum Low (see above) (n=101, 105, 97, 94)	1 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Creatinine >2.5 mg/dL (n=101, 105, 97, 94)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Neutrophils+Bands <1x1000 c/µL(n=101, 105, 97, 93)	0 participants
Placebo	Marked Laboratory Abnormalities - During ST + LT Treatment Period	Sodium,Serum High(see above) (n=101, 105, 97, 94)	0 participants

Other Pre-specified

Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort

Time frame: Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks.

Population: Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period

Arm	Measure	Group	Value (NUMBER)
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Hemoglobin < 8 g/dL (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Hematocrit < 0.75 x pre-Rx (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Platelets < 50 x 10^9 c/L (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Platelets > 1.5 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Leukocytes < 2 x 1000 c/µL (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Neutrophils+Bands <1x1000 c/uL (n=64)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Eosinophils >0.9x1000 c/µL (n=64)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Lymphocytes <=0.75x1000 c/uL (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	ALP >3 x pre-Rx and >ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	ALP >1.5 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	AST >3 x ULN (n=64)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	AST >5 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	AST >10 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	AST >20 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	ALT >3 x ULN (n=64)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	ALT >5 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	ALT >10 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	ALT >20 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Bilirubin Total >2mg/dL (n=64)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Bilirubin Total >1.5xULN (n=64)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Bilirubin Total >2xULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	BUN >2 x pre-Rx and >ULN (n=64)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Creatinine >2.5 mg/dL (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Glucose, Serum Fasting < 50 mg/dL (n=1)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Glucose, Serum Fasting > 500 mg/dL (n=1)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Glucose, Serum Unspec. < 50 mg/dL (n=1)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Glucose, Serum Unspec. > 500 mg/dL (n=1)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Glucose, Plasma Fasting <50 mg/dL (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Glucose,Plasma Fasting >500 mg/dL (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Glucose, Plasma Unspec. <50 mg/dL (n=65)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Glucose,Plasma Unspec. >500 mg/dL (n=65)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Sodium,Serum Low (see above) (n=65)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Sodium,Serum High (see above) (n=65)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Potassium,Serum Low (see above) (n=65)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Potassium, Serum High (see above) (n=65)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Chloride < 90 mEq/L (n=65)	1 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Chloride > 120 mEq/L (n=65)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Albumin < 0.9 LLN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Creatine Kinase > 5 x ULN (n=64)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Uric Acid > 1.5 x ULN (n=0)	0 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Protein Urine, >=2-4 (n=64)	2 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Blood Urine, >=2-4 (n=64)	4 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	Red Blood Cells Urine >=2-4 (n=58)	7 participants
Saxagliptin 2.5 mg	Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort	White Blood Cells Urine >=2-4 (n=58)	6 participants

Other Pre-specified

Overall Summary of Adverse Events During ST+LT Treatment Period

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 Related SAE	0 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Discontinuations Due to AEs	9 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Deaths	0 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 Related AE	25 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 AE	89 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Discontinuations Due to SAEs	6 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 SAE	11 participants
Saxagliptin 5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 SAE	18 participants
Saxagliptin 5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 Related SAE	1 participants
Saxagliptin 5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Discontinuations Due to AEs	10 participants
Saxagliptin 5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 Related AE	23 participants
Saxagliptin 5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 AE	94 participants
Saxagliptin 5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Deaths	0 participants
Saxagliptin 5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Discontinuations Due to SAEs	2 participants
Saxagliptin 10 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 SAE	9 participants
Saxagliptin 10 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 AE	87 participants
Saxagliptin 10 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 Related AE	25 participants
Saxagliptin 10 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Deaths	0 participants
Saxagliptin 10 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 Related SAE	0 participants
Saxagliptin 10 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Discontinuations Due to SAEs	3 participants
Saxagliptin 10 mg	Overall Summary of Adverse Events During ST+LT Treatment Period	Discontinuations Due to AEs	10 participants
Placebo	Overall Summary of Adverse Events During ST+LT Treatment Period	Deaths	1 participants
Placebo	Overall Summary of Adverse Events During ST+LT Treatment Period	Discontinuations Due to AEs	5 participants
Placebo	Overall Summary of Adverse Events During ST+LT Treatment Period	Discontinuations Due to SAEs	1 participants
Placebo	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 Related AE	25 participants
Placebo	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 AE	77 participants
Placebo	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 Related SAE	0 participants
Placebo	Overall Summary of Adverse Events During ST+LT Treatment Period	At Least 1 SAE	11 participants

Other Pre-specified

Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort

Time frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort	At Least 1 AE	49 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort	At Least 1 Related AE	9 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort	Deaths	0 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort	At Least 1 SAE	6 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort	At Least 1 Related SAE	0 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort	Discontinuations Due to SAEs	2 participants
Saxagliptin 2.5 mg	Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort	Discontinuations Due to AEs	5 participants

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026

Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

A1C Changes From Baseline at Week 24 - Open Label Cohort

Hemoglobin A1c (A1C) Changes From Baseline at Week 24

Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)

Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort

Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)

Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort

Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24

Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort

All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period

All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort

Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period

Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period

Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period

Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period

Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period

Baseline and Changes From Baseline in Hematocrit During the ST + LT Period

Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period

Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period

Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period

Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period

Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort

Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort

Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort

Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort

Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period

Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort

Changes From Baseline in Heart Rate During the ST + LT Period

Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort

Changes From Baseline in Systolic Blood Pressure During the ST + LT Period

Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort

Confirmed Hypoglycemia During ST + LT Treatment Period

Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort

Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period

Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort

Marked Laboratory Abnormalities - During ST + LT Treatment Period

Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort

Overall Summary of Adverse Events During ST+LT Treatment Period

Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort