Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone
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 pioglitizone added onto their blinded study medication
Interventions
DRUGSaxagliptin + Metformin
Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
DRUGPlacebo + Metformin
Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)
DRUGPioglitazone
Tablets, Oral, 15 - 45 mg (as needed for rescue)
Sponsors
AstraZeneca
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
No
Inclusion criteria
* Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening. * HbA1c \>= 7.0% and \<= 10.0 % * Body mass index \<= 40 kg/m2 * Fasting C-peptide \>= 1 ng/dL
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 females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Baseline, Week 24 | Mean change from baseline is adjusted for baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Baseline, Week 24 | Mean change from baseline is adjusted for baseline value. |
| Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline, Week 24 | Mean change from baseline is adjusted for baseline value. |
| 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 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 | — |
| 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 | 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 | 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 | 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 | — |
| 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. |
| All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period | AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla | Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. |
| Confirmed Hypoglycemia During the ST + LT Treatment Period | AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla | 'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose \<= 50 mg/dL and associated symptoms. |
| Overall Summary of Adverse Events During ST+LT Treatment Period | AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla | 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: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo. | 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 | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, Mexico, Puerto Rico, Taiwan, United States
Participant flow
Pre-assignment details
1462 participants were enrolled, and 787 entered the lead-in period. 45 discontinued the during the lead-in period. 19 subjects no longer met study criteria, 10 subjects withdrew consent, and 2 subjects were randomized but not treated.
Participants by arm
| Arm | Count |
|---|---|
| Saxagliptin 2.5 mg + Metformin Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue). | 192 |
| Saxagliptin 5 mg + Metformin Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue). | 191 |
| Saxagliptin 10 mg + Metformin Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue). | 181 |
| Placebo+ Metformin Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue). | 179 |
| Total | 743 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Short Term (ST) + Long Term (LT) Period | Adverse Event | 12 | 18 | 13 | 10 |
| Short Term (ST) + Long Term (LT) Period | Death | 1 | 0 | 0 | 2 |
| Short Term (ST) + Long Term (LT) Period | Lack of Efficacy | 54 | 51 | 42 | 65 |
| Short Term (ST) + Long Term (LT) Period | Lost to Follow-up | 11 | 11 | 13 | 16 |
| Short Term (ST) + Long Term (LT) Period | Other Reason | 5 | 7 | 6 | 3 |
| Short Term (ST) + Long Term (LT) Period | Poor / Non-compliance | 3 | 5 | 8 | 4 |
| Short Term (ST) + Long Term (LT) Period | Pregnancy | 1 | 1 | 0 | 1 |
| Short Term (ST) + Long Term (LT) Period | Subject No Longer Meets Study Criteria | 3 | 6 | 5 | 9 |
| Short Term (ST) + Long Term (LT) Period | Subject Withdrew Consent | 38 | 34 | 26 | 30 |
| Short Term (ST) Period | Adverse Event | 5 | 6 | 5 | 3 |
| Short Term (ST) Period | Death | 0 | 0 | 0 | 1 |
| Short Term (ST) Period | Lack of Efficacy | 25 | 22 | 27 | 44 |
| Short Term (ST) Period | Lost to Follow-up | 3 | 4 | 4 | 3 |
| Short Term (ST) Period | Other Reason | 3 | 0 | 0 | 0 |
| Short Term (ST) Period | Poor / Non-compliance | 0 | 1 | 1 | 2 |
| Short Term (ST) Period | Pregnancy | 0 | 0 | 0 | 1 |
| Short Term (ST) Period | Subject No Longer Meets Study Criteria | 0 | 2 | 0 | 2 |
| Short Term (ST) Period | Subject Withdrew Consent | 8 | 13 | 4 | 11 |
Baseline characteristics
| Characteristic | Saxagliptin 2.5 mg + Metformin | Total | Placebo+ Metformin | Saxagliptin 10 mg + Metformin | Saxagliptin 5 mg + Metformin |
|---|---|---|---|---|---|
| Age Characterization Female Only =< 50 years | 33 participants | 112 participants | 21 participants | 24 participants | 34 participants |
| Age Characterization Female Only > 50 years | 76 participants | 254 participants | 62 participants | 62 participants | 54 participants |
| Age, Continuous | 54.66 years STANDARD_DEVIATION 10.08 | 54.57 years STANDARD_DEVIATION 9.98 | 54.76 years STANDARD_DEVIATION 10.18 | 54.18 years STANDARD_DEVIATION 10.14 | 54.69 years STANDARD_DEVIATION 9.62 |
| Age, Customized < 65 years | 159 participants | 626 participants | 153 participants | 155 participants | 159 participants |
| Age, Customized >= 65 years | 33 participants | 117 participants | 26 participants | 26 participants | 32 participants |
| Age, Customized >= 75 years | 3 participants | 13 participants | 3 participants | 5 participants | 2 participants |
| Body Mass Index | 31.68 kg/m^2 STANDARD_DEVIATION 5.15 | 31.40 kg/m^2 STANDARD_DEVIATION 4.85 | 31.57 kg/m^2 STANDARD_DEVIATION 4.8 | 31.12 kg/m^2 STANDARD_DEVIATION 4.79 | 31.23 kg/m^2 STANDARD_DEVIATION 4.67 |
| Body Mass Index Categorization < 30 | 75 Participants | 317 Participants | 76 Participants | 82 Participants | 84 Participants |
| Body Mass Index Categorization >= 30 | 117 Participants | 426 Participants | 103 Participants | 99 Participants | 107 Participants |
| Race/Ethnicity, Customized Asian | 8 participants | 20 participants | 4 participants | 5 participants | 3 participants |
| Race/Ethnicity, Customized Black / African American | 8 participants | 40 participants | 7 participants | 14 participants | 11 participants |
| Race/Ethnicity, Customized Hispanic / Latino | 27 participants | 108 participants | 27 participants | 29 participants | 25 participants |
| Race/Ethnicity, Customized Not Hispanic / Latino | 64 participants | 229 participants | 49 participants | 54 participants | 62 participants |
| Race/Ethnicity, Customized Not Reported | 101 participants | 406 participants | 103 participants | 98 participants | 104 participants |
| Race/Ethnicity, Customized Other | 23 participants | 77 participants | 18 participants | 18 participants | 18 participants |
| Race/Ethnicity, Customized White | 153 participants | 606 participants | 150 participants | 144 participants | 159 participants |
| Sex: Female, Male Female | 109 Participants | 366 Participants | 83 Participants | 86 Participants | 88 Participants |
| Sex: Female, Male Male | 83 Participants | 377 Participants | 96 Participants | 95 Participants | 103 Participants |
| Weight | 85.97 kg STANDARD_DEVIATION 17.57 | 87.04 kg STANDARD_DEVIATION 17.79 | 87.14 kg STANDARD_DEVIATION 17.75 | 87.83 kg STANDARD_DEVIATION 18.9 | 87.26 kg STANDARD_DEVIATION 17.04 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 129 / 179 | 133 / 181 | 139 / 192 | 133 / 191 |
| serious Total, serious adverse events | 15 / 179 | 22 / 181 | 23 / 192 | 27 / 191 |
Outcome results
Primary
Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Mean change from baseline is adjusted for baseline value.
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 + Metformin | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Baseline Mean | 8.08 percentage of glycosylated hemoglobins | Standard Error 0.07 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Adjusted Mean Change from Baseline | -0.59 percentage of glycosylated hemoglobins | Standard Error 0.07 |
| Saxagliptin 5 mg + Metformin | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Baseline Mean | 8.07 percentage of glycosylated hemoglobins | Standard Error 0.06 |
| Saxagliptin 5 mg + Metformin | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Adjusted Mean Change from Baseline | -0.69 percentage of glycosylated hemoglobins | Standard Error 0.07 |
| Saxagliptin 10 mg + Metformin | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Adjusted Mean Change from Baseline | -0.58 percentage of glycosylated hemoglobins | Standard Error 0.07 |
| Saxagliptin 10 mg + Metformin | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Baseline Mean | 7.98 percentage of glycosylated hemoglobins | Standard Error 0.08 |
| Placebo+ Metformin | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Adjusted Mean Change from Baseline | 0.13 percentage of glycosylated hemoglobins | Standard Error 0.07 |
| Placebo+ Metformin | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | Baseline Mean | 8.06 percentage of glycosylated hemoglobins | Standard Error 0.07 |
p-value: <0.000195% CI: [-0.92, -0.53]ANCOVA
p-value: <0.000195% CI: [-1.02, -0.63]ANCOVA
p-value: <0.000195% CI: [-0.91, -0.52]ANCOVA
Secondary
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
Mean change from baseline is adjusted for baseline value.
Time frame: Baseline, Week 24
Population: Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Baseline Mean | 48224 mg*min/dL | Standard Error 869.7 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Adjusted Mean Change from Baseline | -8891 mg*min/dL | Standard Error 797.97 |
| Saxagliptin 5 mg + Metformin | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Adjusted Mean Change from Baseline | -9586 mg*min/dL | Standard Error 810.46 |
| Saxagliptin 5 mg + Metformin | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Baseline Mean | 49021 mg*min/dL | Standard Error 876.17 |
| Saxagliptin 10 mg + Metformin | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Baseline Mean | 44931 mg*min/dL | Standard Error 889.85 |
| Saxagliptin 10 mg + Metformin | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Adjusted Mean Change from Baseline | -8137 mg*min/dL | Standard Error 807.88 |
| Placebo+ Metformin | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Baseline Mean | 47407 mg*min/dL | Standard Error 1071.9 |
| Placebo+ Metformin | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | Adjusted Mean Change from Baseline | -3291 mg*min/dL | Standard Error 853.24 |
p-value: <0.000195% CI: [-7894, -3305]ANCOVA
p-value: <0.000195% CI: [-8606, -3983]ANCOVA
p-value: <0.000195% CI: [-7153, -2537]ANCOVA
Secondary
Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Mean change from baseline is adjusted for baseline value.
Time frame: Baseline, Week 24
Population: Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin | Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline Mean | 173.57 mg/dL | Standard Error 3.23 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Adjusted Mean Change from Baseline | -14.31 mg/dL | Standard Error 2.48 |
| Saxagliptin 5 mg + Metformin | Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Adjusted Mean Change from Baseline | -22.03 mg/dL | Standard Error 2.49 |
| Saxagliptin 5 mg + Metformin | Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline Mean | 179.03 mg/dL | Standard Error 3.44 |
| Saxagliptin 10 mg + Metformin | Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline Mean | 175.86 mg/dL | Standard Error 3.73 |
| Saxagliptin 10 mg + Metformin | Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Adjusted Mean Change from Baseline | -20.50 mg/dL | Standard Error 2.53 |
| Placebo+ Metformin | Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline Mean | 174.94 mg/dL | Standard Error 3.27 |
| Placebo+ Metformin | Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Adjusted Mean Change from Baseline | 1.24 mg/dL | Standard Error 2.56 |
p-value: <0.000195% CI: [-22.55, -8.55]ANCOVA
p-value: <0.000195% CI: [-30.29, -16.27]ANCOVA
p-value: <0.000195% CI: [-28.81, -14.68]ANCOVA
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 + Metformin | Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 | 37.1 percentage of participants |
| Saxagliptin 5 mg + Metformin | Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 | 43.5 percentage of participants |
| Saxagliptin 10 mg + Metformin | Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 | 44.4 percentage of participants |
| Placebo+ Metformin | Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 | 16.6 percentage of participants |
p-value: <0.000195% CI: [10.6, 30.5]Fisher Exact
p-value: <0.000195% CI: [17, 36.7]Fisher Exact
p-value: <0.000195% CI: [17.7, 37.7]Fisher Exact
Other Pre-specified
All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period
Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.
Time frame: AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla
Population: Treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 2.5 mg + Metformin | All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period | 23 participants |
| Saxagliptin 5 mg + Metformin | All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period | 20 participants |
| Saxagliptin 10 mg + Metformin | All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period | 21 participants |
| Placebo+ Metformin | All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period | 20 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 + Metformin | Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.02 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 71, 40) | 0.01 10^3 c/µL | Standard Error 0.006 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 142, 145, 124) | 0.01 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=172, 172, 163, 153) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=98, 92, 95, 57) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 2.5 mg + Metformin | 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=147, 136, 140, 115) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 2.5 mg + Metformin | 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=134, 126, 130, 94) | 0.02 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 149, 146, 121) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=104, 104, 111, 68) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 2.5 mg + Metformin | 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=122, 113, 123, 85) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 2.5 mg + Metformin | 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=148, 130, 137, 128) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 72, 41) | -0.00 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 2.5 mg + Metformin | 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=168, 166, 159, 141) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 2.5 mg + Metformin | 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=61, 48, 63, 31) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 2.5 mg + Metformin | 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=156, 152, 145, 136) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=176, 175, 170, 166) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=76, 67, 75, 42) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 2.5 mg + Metformin | 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=166, 166, 157, 137) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=155, 157, 149, 139) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 2.5 mg + Metformin | 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=77, 71, 78, 45) | 0.00 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 153, 154, 146) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=157, 151, 143, 138) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=175, 172, 165, 158) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=85, 78, 84, 47) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 160, 157, 135) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 2.5 mg + Metformin | 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=159, 155, 154, 136) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 2.5 mg + Metformin | 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=178, 175, 170, 169) | -0.00 10^3 c/µL | Standard Error 0.002 |
| Saxagliptin 2.5 mg + Metformin | 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=90, 87, 88, 50) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 71, 40) | 0.00 10^3 c/µL | Standard Error 0.006 |
| Saxagliptin 5 mg + Metformin | 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=150, 149, 146, 121) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=156, 152, 145, 136) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=98, 92, 95, 57) | 0.01 10^3 c/µL | Standard Error 0.006 |
| Saxagliptin 5 mg + Metformin | 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=85, 78, 84, 47) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 5 mg + Metformin | 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=150, 142, 145, 124) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 5 mg + Metformin | 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=162, 160, 157, 135) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=157, 151, 143, 138) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 5 mg + Metformin | 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=166, 166, 157, 137) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=147, 136, 140, 115) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 5 mg + Metformin | 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=172, 172, 163, 153) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=104, 104, 111, 68) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 5 mg + Metformin | 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=176, 175, 170, 166) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=134, 126, 130, 94) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 5 mg + Metformin | 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=77, 71, 78, 45) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 5 mg + Metformin | 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=175, 172, 165, 158) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=155, 157, 149, 139) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 5 mg + Metformin | 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=122, 113, 123, 85) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 5 mg + Metformin | 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=178, 175, 170, 169) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 72, 41) | -0.00 10^3 c/µL | Standard Error 0.006 |
| Saxagliptin 5 mg + Metformin | 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=61, 48, 63, 31) | 0.01 10^3 c/µL | Standard Error 0.006 |
| Saxagliptin 5 mg + Metformin | 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=148, 130, 137, 128) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.02 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=90, 87, 88, 50) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 5 mg + Metformin | 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=159, 155, 154, 136) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=168, 166, 159, 141) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 5 mg + Metformin | 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=162, 153, 154, 146) | -0.01 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 5 mg + Metformin | 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=76, 67, 75, 42) | 0.01 10^3 c/µL | Standard Error 0.006 |
| Saxagliptin 10 mg + Metformin | 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=134, 126, 130, 94) | 0.02 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.02 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=178, 175, 170, 169) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=176, 175, 170, 166) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 10 mg + Metformin | 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=175, 172, 165, 158) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=172, 172, 163, 153) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=148, 130, 137, 128) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=168, 166, 159, 141) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=156, 152, 145, 136) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=166, 166, 157, 137) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=155, 157, 149, 139) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=162, 153, 154, 146) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=157, 151, 143, 138) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=162, 160, 157, 135) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=159, 155, 154, 136) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 10 mg + Metformin | 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=150, 149, 146, 121) | 0.01 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=150, 142, 145, 124) | 0.01 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=147, 136, 140, 115) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 10 mg + Metformin | 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=122, 113, 123, 85) | 0.01 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=104, 104, 111, 68) | 0.02 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 10 mg + Metformin | 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=98, 92, 95, 57) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 10 mg + Metformin | 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=90, 87, 88, 50) | 0.02 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 10 mg + Metformin | 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=85, 78, 84, 47) | 0.01 10^3 c/µL | Standard Error 0.003 |
| Saxagliptin 10 mg + Metformin | 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=77, 71, 78, 45) | 0.00 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 10 mg + Metformin | 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=76, 67, 75, 42) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 72, 41) | 0.01 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 71, 40) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Saxagliptin 10 mg + Metformin | 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=61, 48, 63, 31) | 0.01 10^3 c/µL | Standard Error 0.005 |
| Placebo+ Metformin | 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=159, 155, 154, 136) | 0.00 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | 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=162, 160, 157, 135) | -0.00 10^3 c/µL | Standard Error 0.004 |
| Placebo+ Metformin | 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=176, 175, 170, 166) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | 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=90, 87, 88, 50) | -0.00 10^3 c/µL | Standard Error 0.008 |
| Placebo+ Metformin | 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=157, 151, 143, 138) | -0.00 10^3 c/µL | Standard Error 0.005 |
| Placebo+ Metformin | 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=162, 153, 154, 146) | -0.00 10^3 c/µL | Standard Error 0.004 |
| Placebo+ Metformin | 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=61, 48, 63, 31) | -0.01 10^3 c/µL | Standard Error 0.008 |
| Placebo+ Metformin | 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=85, 78, 84, 47) | -0.01 10^3 c/µL | Standard Error 0.008 |
| Placebo+ Metformin | 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=155, 157, 149, 139) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | 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=166, 166, 157, 137) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | 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=69, 60, 71, 40) | -0.01 10^3 c/µL | Standard Error 0.008 |
| Placebo+ Metformin | 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=77, 71, 78, 45) | -0.01 10^3 c/µL | Standard Error 0.007 |
| Placebo+ Metformin | 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=156, 152, 145, 136) | -0.01 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | 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=168, 166, 159, 141) | -0.01 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | 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=178, 175, 170, 169) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | 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=76, 67, 75, 42) | -0.00 10^3 c/µL | Standard Error 0.008 |
| Placebo+ Metformin | 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=148, 130, 137, 128) | -0.00 10^3 c/µL | Standard Error 0.004 |
| Placebo+ Metformin | 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=172, 172, 163, 153) | -0.00 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.02 10^3 c/µL | Standard Error 0.003 |
| Placebo+ Metformin | 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=122, 113, 123, 85) | 0.00 10^3 c/µL | Standard Error 0.005 |
| Placebo+ Metformin | 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=134, 126, 130, 94) | 0.00 10^3 c/µL | Standard Error 0.005 |
| Placebo+ Metformin | 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=147, 136, 140, 115) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Placebo+ Metformin | 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=69, 60, 72, 41) | -0.01 10^3 c/µL | Standard Error 0.006 |
| Placebo+ Metformin | 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=104, 104, 111, 68) | -0.00 10^3 c/µL | Standard Error 0.006 |
| Placebo+ Metformin | 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=150, 142, 145, 124) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Placebo+ Metformin | 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=150, 149, 146, 121) | -0.00 10^3 c/µL | Standard Error 0.004 |
| Placebo+ Metformin | 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=175, 172, 165, 158) | 0.00 10^3 c/µL | Standard Error 0.004 |
| Placebo+ Metformin | 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=98, 92, 95, 57) | 0.00 10^3 c/µL | Standard Error 0.007 |
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 + Metformin | Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.24 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 71, 40) | -0.02 10^3 c/µL | Standard Error 0.02 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 142, 145, 124) | -0.03 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 2.5 mg + Metformin | 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=172, 172, 163, 153) | -0.00 10^3 c/µL | Standard Error 0.019 |
| Saxagliptin 2.5 mg + Metformin | 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=98, 92, 95, 57) | 0.00 10^3 c/µL | Standard Error 0.049 |
| Saxagliptin 2.5 mg + Metformin | 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=147, 136, 140, 115) | -0.00 10^3 c/µL | Standard Error 0.026 |
| Saxagliptin 2.5 mg + Metformin | 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=134, 126, 130, 94) | -0.01 10^3 c/µL | Standard Error 0.031 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 149, 146, 121) | -0.00 10^3 c/µL | Standard Error 0.037 |
| Saxagliptin 2.5 mg + Metformin | 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=104, 104, 111, 68) | -0.01 10^3 c/µL | Standard Error 0.052 |
| Saxagliptin 2.5 mg + Metformin | 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=122, 113, 123, 85) | -0.02 10^3 c/µL | Standard Error 0.028 |
| Saxagliptin 2.5 mg + Metformin | 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=148, 130, 137, 128) | -0.02 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 72, 41) | 0.03 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 2.5 mg + Metformin | 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=168, 166, 159, 141) | -0.02 10^3 c/µL | Standard Error 0.019 |
| Saxagliptin 2.5 mg + Metformin | 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=61, 48, 63, 31) | -0.03 10^3 c/µL | Standard Error 0.019 |
| Saxagliptin 2.5 mg + Metformin | 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=156, 152, 145, 136) | 0.01 10^3 c/µL | Standard Error 0.022 |
| Saxagliptin 2.5 mg + Metformin | 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=176, 175, 170, 166) | -0.01 10^3 c/µL | Standard Error 0.023 |
| Saxagliptin 2.5 mg + Metformin | 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=76, 67, 75, 42) | 0.01 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 2.5 mg + Metformin | 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=166, 166, 157, 137) | -0.02 10^3 c/µL | Standard Error 0.023 |
| Saxagliptin 2.5 mg + Metformin | 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=155, 157, 149, 139) | -0.01 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=77, 71, 78, 45) | -0.01 10^3 c/µL | Standard Error 0.051 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 153, 154, 146) | -0.04 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 2.5 mg + Metformin | 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=157, 151, 143, 138) | -0.01 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 2.5 mg + Metformin | 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=175, 172, 165, 158) | -0.02 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 2.5 mg + Metformin | 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=85, 78, 84, 47) | -0.01 10^3 c/µL | Standard Error 0.032 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 160, 157, 135) | -0.03 10^3 c/µL | Standard Error 0.022 |
| Saxagliptin 2.5 mg + Metformin | 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=159, 155, 154, 136) | -0.02 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 2.5 mg + Metformin | 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=178, 175, 170, 169) | -0.02 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 2.5 mg + Metformin | 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=90, 87, 88, 50) | -0.01 10^3 c/µL | Standard Error 0.051 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 71, 40) | -0.00 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 5 mg + Metformin | 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=150, 149, 146, 121) | -0.02 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 5 mg + Metformin | 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=156, 152, 145, 136) | -0.01 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 5 mg + Metformin | 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=98, 92, 95, 57) | -0.02 10^3 c/µL | Standard Error 0.025 |
| Saxagliptin 5 mg + Metformin | 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=85, 78, 84, 47) | -0.03 10^3 c/µL | Standard Error 0.024 |
| Saxagliptin 5 mg + Metformin | 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=150, 142, 145, 124) | -0.02 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 5 mg + Metformin | 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=162, 160, 157, 135) | -0.01 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 5 mg + Metformin | 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=157, 151, 143, 138) | -0.00 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 5 mg + Metformin | 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=166, 166, 157, 137) | 0.00 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 5 mg + Metformin | 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=147, 136, 140, 115) | -0.02 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 5 mg + Metformin | 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=172, 172, 163, 153) | -0.01 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 5 mg + Metformin | 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=104, 104, 111, 68) | 0.00 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 5 mg + Metformin | 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=176, 175, 170, 166) | -0.01 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 5 mg + Metformin | 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=134, 126, 130, 94) | -0.01 10^3 c/µL | Standard Error 0.02 |
| Saxagliptin 5 mg + Metformin | 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=77, 71, 78, 45) | -0.02 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 5 mg + Metformin | 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=175, 172, 165, 158) | -0.01 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 5 mg + Metformin | 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=155, 157, 149, 139) | -0.00 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 5 mg + Metformin | 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=122, 113, 123, 85) | -0.05 10^3 c/µL | Standard Error 0.023 |
| Saxagliptin 5 mg + Metformin | 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=178, 175, 170, 169) | 0.01 10^3 c/µL | Standard Error 0.01 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 72, 41) | -0.03 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 5 mg + Metformin | 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=61, 48, 63, 31) | -0.03 10^3 c/µL | Standard Error 0.02 |
| Saxagliptin 5 mg + Metformin | 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=148, 130, 137, 128) | -0.01 10^3 c/µL | Standard Error 0.019 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.23 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 5 mg + Metformin | 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=90, 87, 88, 50) | -0.02 10^3 c/µL | Standard Error 0.027 |
| Saxagliptin 5 mg + Metformin | 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=159, 155, 154, 136) | -0.01 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 5 mg + Metformin | 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=168, 166, 159, 141) | -0.01 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 5 mg + Metformin | 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=162, 153, 154, 146) | -0.01 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 5 mg + Metformin | 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=76, 67, 75, 42) | -0.01 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 10 mg + Metformin | 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=134, 126, 130, 94) | -0.01 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.24 10^3 c/µL | Standard Error 0.024 |
| Saxagliptin 10 mg + Metformin | 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=178, 175, 170, 169) | -0.00 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 10 mg + Metformin | 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=176, 175, 170, 166) | -0.02 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 10 mg + Metformin | 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=175, 172, 165, 158) | -0.03 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | 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=172, 172, 163, 153) | -0.02 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=148, 130, 137, 128) | -0.02 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 10 mg + Metformin | 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=168, 166, 159, 141) | -0.03 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 10 mg + Metformin | 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=156, 152, 145, 136) | -0.02 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 10 mg + Metformin | 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=166, 166, 157, 137) | -0.02 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 10 mg + Metformin | 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=155, 157, 149, 139) | -0.00 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 10 mg + Metformin | 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=162, 153, 154, 146) | -0.02 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 10 mg + Metformin | 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=157, 151, 143, 138) | 0.00 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=162, 160, 157, 135) | -0.01 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 10 mg + Metformin | 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=159, 155, 154, 136) | 0.00 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | 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=150, 149, 146, 121) | -0.03 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=150, 142, 145, 124) | 0.02 10^3 c/µL | Standard Error 0.03 |
| Saxagliptin 10 mg + Metformin | 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=147, 136, 140, 115) | -0.01 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 10 mg + Metformin | 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=122, 113, 123, 85) | -0.01 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 10 mg + Metformin | 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=104, 104, 111, 68) | 0.01 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 10 mg + Metformin | 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=98, 92, 95, 57) | 0.00 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 10 mg + Metformin | 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=90, 87, 88, 50) | 0.01 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 10 mg + Metformin | 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=85, 78, 84, 47) | -0.01 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 10 mg + Metformin | 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=77, 71, 78, 45) | -0.00 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 10 mg + Metformin | 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=76, 67, 75, 42) | 0.00 10^3 c/µL | Standard Error 0.02 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 72, 41) | -0.01 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 71, 40) | -0.00 10^3 c/µL | Standard Error 0.023 |
| Saxagliptin 10 mg + Metformin | 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=61, 48, 63, 31) | 0.03 10^3 c/µL | Standard Error 0.031 |
| Placebo+ Metformin | 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=159, 155, 154, 136) | 0.00 10^3 c/µL | Standard Error 0.012 |
| Placebo+ Metformin | 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=162, 160, 157, 135) | 0.01 10^3 c/µL | Standard Error 0.011 |
| Placebo+ Metformin | 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=176, 175, 170, 166) | 0.00 10^3 c/µL | Standard Error 0.007 |
| Placebo+ Metformin | 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=90, 87, 88, 50) | -0.03 10^3 c/µL | Standard Error 0.021 |
| Placebo+ Metformin | 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=157, 151, 143, 138) | 0.03 10^3 c/µL | Standard Error 0.014 |
| Placebo+ Metformin | 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=162, 153, 154, 146) | 0.02 10^3 c/µL | Standard Error 0.013 |
| Placebo+ Metformin | 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=61, 48, 63, 31) | -0.09 10^3 c/µL | Standard Error 0.028 |
| Placebo+ Metformin | 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=85, 78, 84, 47) | -0.01 10^3 c/µL | Standard Error 0.032 |
| Placebo+ Metformin | 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=155, 157, 149, 139) | 0.04 10^3 c/µL | Standard Error 0.015 |
| Placebo+ Metformin | 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=166, 166, 157, 137) | 0.04 10^3 c/µL | Standard Error 0.016 |
| Placebo+ Metformin | 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=69, 60, 71, 40) | -0.04 10^3 c/µL | Standard Error 0.025 |
| Placebo+ Metformin | 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=77, 71, 78, 45) | -0.03 10^3 c/µL | Standard Error 0.02 |
| Placebo+ Metformin | 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=156, 152, 145, 136) | 0.02 10^3 c/µL | Standard Error 0.013 |
| Placebo+ Metformin | 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=168, 166, 159, 141) | 0.00 10^3 c/µL | Standard Error 0.009 |
| Placebo+ Metformin | 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=178, 175, 170, 169) | 0.00 10^3 c/µL | Standard Error 0.007 |
| Placebo+ Metformin | 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=76, 67, 75, 42) | -0.05 10^3 c/µL | Standard Error 0.019 |
| Placebo+ Metformin | 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=148, 130, 137, 128) | 0.01 10^3 c/µL | Standard Error 0.011 |
| Placebo+ Metformin | 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=172, 172, 163, 153) | 0.00 10^3 c/µL | Standard Error 0.01 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.21 10^3 c/µL | Standard Error 0.013 |
| Placebo+ Metformin | 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=122, 113, 123, 85) | -0.03 10^3 c/µL | Standard Error 0.015 |
| Placebo+ Metformin | 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=134, 126, 130, 94) | -0.03 10^3 c/µL | Standard Error 0.015 |
| Placebo+ Metformin | 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=147, 136, 140, 115) | -0.01 10^3 c/µL | Standard Error 0.015 |
| Placebo+ Metformin | 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=69, 60, 72, 41) | -0.04 10^3 c/µL | Standard Error 0.023 |
| Placebo+ Metformin | 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=104, 104, 111, 68) | -0.03 10^3 c/µL | Standard Error 0.018 |
| Placebo+ Metformin | 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=150, 142, 145, 124) | -0.02 10^3 c/µL | Standard Error 0.011 |
| Placebo+ Metformin | 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=150, 149, 146, 121) | -0.01 10^3 c/µL | Standard Error 0.011 |
| Placebo+ Metformin | 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=175, 172, 165, 158) | 0.01 10^3 c/µL | Standard Error 0.009 |
| Placebo+ Metformin | 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=98, 92, 95, 57) | -0.03 10^3 c/µL | Standard Error 0.022 |
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 + Metformin | Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 2.29 10^3 c/µL | Standard Error 0.051 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 71, 40) | -0.18 10^3 c/µL | Standard Error 0.069 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 142, 145, 124) | -0.12 10^3 c/µL | Standard Error 0.038 |
| Saxagliptin 2.5 mg + Metformin | 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=172, 172, 163, 153) | -0.01 10^3 c/µL | Standard Error 0.038 |
| Saxagliptin 2.5 mg + Metformin | 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=98, 92, 95, 58) | -0.13 10^3 c/µL | Standard Error 0.057 |
| Saxagliptin 2.5 mg + Metformin | 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=147, 136, 140, 115) | -0.12 10^3 c/µL | Standard Error 0.042 |
| Saxagliptin 2.5 mg + Metformin | 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=134, 126, 130, 94) | -0.11 10^3 c/µL | Standard Error 0.047 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 149, 146, 121) | 0.04 10^3 c/µL | Standard Error 0.045 |
| Saxagliptin 2.5 mg + Metformin | 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=104, 104, 111, 68) | -0.20 10^3 c/µL | Standard Error 0.05 |
| Saxagliptin 2.5 mg + Metformin | 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=122, 114, 123, 85) | -0.14 10^3 c/µL | Standard Error 0.053 |
| Saxagliptin 2.5 mg + Metformin | 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=148, 130, 137, 128) | 0.12 10^3 c/µL | Standard Error 0.046 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 72, 41) | -0.21 10^3 c/µL | Standard Error 0.059 |
| Saxagliptin 2.5 mg + Metformin | 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=168, 166, 159, 141) | -0.02 10^3 c/µL | Standard Error 0.041 |
| Saxagliptin 2.5 mg + Metformin | 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=61, 48, 63, 31) | -0.40 10^3 c/µL | Standard Error 0.07 |
| Saxagliptin 2.5 mg + Metformin | 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=156, 152, 145, 136) | 0.13 10^3 c/µL | Standard Error 0.045 |
| Saxagliptin 2.5 mg + Metformin | 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=176, 175, 170, 166) | -0.02 10^3 c/µL | Standard Error 0.035 |
| Saxagliptin 2.5 mg + Metformin | 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=77, 67, 75, 42) | -0.11 10^3 c/µL | Standard Error 0.065 |
| Saxagliptin 2.5 mg + Metformin | 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=166, 166, 157, 137) | 0.04 10^3 c/µL | Standard Error 0.045 |
| Saxagliptin 2.5 mg + Metformin | 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=155, 157, 149, 139) | 0.22 10^3 c/µL | Standard Error 0.049 |
| Saxagliptin 2.5 mg + Metformin | 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=78, 71, 78, 45) | -0.23 10^3 c/µL | Standard Error 0.058 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 153, 154, 146) | 0.08 10^3 c/µL | Standard Error 0.04 |
| Saxagliptin 2.5 mg + Metformin | 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=157, 151, 143, 138) | 0.16 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 2.5 mg + Metformin | 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=175, 172, 165, 158) | -0.03 10^3 c/µL | Standard Error 0.04 |
| Saxagliptin 2.5 mg + Metformin | 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=85, 78, 84, 48) | -0.04 10^3 c/µL | Standard Error 0.067 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 160, 157, 135) | 0.07 10^3 c/µL | Standard Error 0.045 |
| Saxagliptin 2.5 mg + Metformin | 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=159, 155, 154, 136) | 0.06 10^3 c/µL | Standard Error 0.04 |
| Saxagliptin 2.5 mg + Metformin | 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=178, 175, 170, 169) | -0.02 10^3 c/µL | Standard Error 0.037 |
| Saxagliptin 2.5 mg + Metformin | 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=91, 88, 88, 50) | -0.15 10^3 c/µL | Standard Error 0.061 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 71, 40) | -0.31 10^3 c/µL | Standard Error 0.081 |
| Saxagliptin 5 mg + Metformin | 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=150, 149, 146, 121) | 0.00 10^3 c/µL | Standard Error 0.041 |
| Saxagliptin 5 mg + Metformin | 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=156, 152, 145, 136) | 0.04 10^3 c/µL | Standard Error 0.039 |
| Saxagliptin 5 mg + Metformin | 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=98, 92, 95, 58) | -0.15 10^3 c/µL | Standard Error 0.056 |
| Saxagliptin 5 mg + Metformin | 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=85, 78, 84, 48) | -0.20 10^3 c/µL | Standard Error 0.058 |
| Saxagliptin 5 mg + Metformin | 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=150, 142, 145, 124) | -0.17 10^3 c/µL | Standard Error 0.04 |
| Saxagliptin 5 mg + Metformin | 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=162, 160, 157, 135) | -0.02 10^3 c/µL | Standard Error 0.041 |
| Saxagliptin 5 mg + Metformin | 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=157, 151, 143, 138) | 0.05 10^3 c/µL | Standard Error 0.043 |
| Saxagliptin 5 mg + Metformin | 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=166, 166, 157, 137) | -0.08 10^3 c/µL | Standard Error 0.038 |
| Saxagliptin 5 mg + Metformin | 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=147, 136, 140, 115) | -0.17 10^3 c/µL | Standard Error 0.043 |
| Saxagliptin 5 mg + Metformin | 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=172, 172, 163, 153) | -0.04 10^3 c/µL | Standard Error 0.039 |
| Saxagliptin 5 mg + Metformin | 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=104, 104, 111, 68) | -0.14 10^3 c/µL | Standard Error 0.058 |
| Saxagliptin 5 mg + Metformin | 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=176, 175, 170, 166) | -0.04 10^3 c/µL | Standard Error 0.037 |
| Saxagliptin 5 mg + Metformin | 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=134, 126, 130, 94) | -0.23 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 5 mg + Metformin | 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=78, 71, 78, 45) | -0.28 10^3 c/µL | Standard Error 0.079 |
| Saxagliptin 5 mg + Metformin | 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=175, 172, 165, 158) | -0.06 10^3 c/µL | Standard Error 0.033 |
| Saxagliptin 5 mg + Metformin | 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=155, 157, 149, 139) | 0.04 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 5 mg + Metformin | 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=122, 114, 123, 85) | -0.23 10^3 c/µL | Standard Error 0.062 |
| Saxagliptin 5 mg + Metformin | 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=178, 175, 170, 169) | -0.07 10^3 c/µL | Standard Error 0.036 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 72, 41) | -0.35 10^3 c/µL | Standard Error 0.072 |
| Saxagliptin 5 mg + Metformin | 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=61, 48, 63, 31) | -0.39 10^3 c/µL | Standard Error 0.085 |
| Saxagliptin 5 mg + Metformin | 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=148, 130, 137, 128) | 0.07 10^3 c/µL | Standard Error 0.049 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 2.29 10^3 c/µL | Standard Error 0.057 |
| Saxagliptin 5 mg + Metformin | 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=91, 88, 88, 50) | -0.24 10^3 c/µL | Standard Error 0.057 |
| Saxagliptin 5 mg + Metformin | 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=159, 155, 154, 136) | 0.03 10^3 c/µL | Standard Error 0.045 |
| Saxagliptin 5 mg + Metformin | 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=168, 166, 159, 141) | -0.02 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 5 mg + Metformin | 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=162, 153, 154, 146) | -0.07 10^3 c/µL | Standard Error 0.043 |
| Saxagliptin 5 mg + Metformin | 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=77, 67, 75, 42) | -0.25 10^3 c/µL | Standard Error 0.081 |
| Saxagliptin 10 mg + Metformin | 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=134, 126, 130, 94) | -0.30 10^3 c/µL | Standard Error 0.046 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 2.23 10^3 c/µL | Standard Error 0.051 |
| Saxagliptin 10 mg + Metformin | 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=178, 175, 170, 169) | -0.03 10^3 c/µL | Standard Error 0.038 |
| Saxagliptin 10 mg + Metformin | 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=176, 175, 170, 166) | -0.13 10^3 c/µL | Standard Error 0.035 |
| Saxagliptin 10 mg + Metformin | 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=175, 172, 165, 158) | -0.12 10^3 c/µL | Standard Error 0.037 |
| Saxagliptin 10 mg + Metformin | 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=172, 172, 163, 153) | -0.13 10^3 c/µL | Standard Error 0.038 |
| Saxagliptin 10 mg + Metformin | 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=148, 130, 137, 128) | -0.03 10^3 c/µL | Standard Error 0.051 |
| Saxagliptin 10 mg + Metformin | 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=168, 166, 159, 141) | -0.11 10^3 c/µL | Standard Error 0.043 |
| Saxagliptin 10 mg + Metformin | 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=156, 152, 145, 136) | -0.08 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 10 mg + Metformin | 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=166, 166, 157, 137) | -0.12 10^3 c/µL | Standard Error 0.047 |
| Saxagliptin 10 mg + Metformin | 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=155, 157, 149, 139) | -0.06 10^3 c/µL | Standard Error 0.048 |
| Saxagliptin 10 mg + Metformin | 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=162, 153, 154, 146) | -0.12 10^3 c/µL | Standard Error 0.039 |
| Saxagliptin 10 mg + Metformin | 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=157, 151, 143, 138) | -0.09 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 10 mg + Metformin | 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=162, 160, 157, 135) | -0.09 10^3 c/µL | Standard Error 0.039 |
| Saxagliptin 10 mg + Metformin | 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=159, 155, 154, 136) | -0.07 10^3 c/µL | Standard Error 0.048 |
| Saxagliptin 10 mg + Metformin | 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=150, 149, 146, 121) | -0.17 10^3 c/µL | Standard Error 0.048 |
| Saxagliptin 10 mg + Metformin | 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=150, 142, 145, 124) | -0.25 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 10 mg + Metformin | 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=147, 136, 140, 115) | -0.30 10^3 c/µL | Standard Error 0.042 |
| Saxagliptin 10 mg + Metformin | 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=122, 114, 123, 85) | -0.33 10^3 c/µL | Standard Error 0.047 |
| Saxagliptin 10 mg + Metformin | 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=104, 104, 111, 68) | -0.30 10^3 c/µL | Standard Error 0.044 |
| Saxagliptin 10 mg + Metformin | 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=98, 92, 95, 58) | -0.23 10^3 c/µL | Standard Error 0.057 |
| Saxagliptin 10 mg + Metformin | 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=91, 88, 88, 50) | -0.28 10^3 c/µL | Standard Error 0.053 |
| Saxagliptin 10 mg + Metformin | 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=85, 78, 84, 48) | -0.22 10^3 c/µL | Standard Error 0.06 |
| Saxagliptin 10 mg + Metformin | 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=78, 71, 78, 45) | -0.35 10^3 c/µL | Standard Error 0.075 |
| Saxagliptin 10 mg + Metformin | 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=77, 67, 75, 42) | -0.24 10^3 c/µL | Standard Error 0.058 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 72, 41) | -0.26 10^3 c/µL | Standard Error 0.074 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 71, 40) | -0.30 10^3 c/µL | Standard Error 0.071 |
| Saxagliptin 10 mg + Metformin | 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=61, 48, 63, 31) | -0.36 10^3 c/µL | Standard Error 0.067 |
| Placebo+ Metformin | 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=159, 155, 154, 136) | 0.04 10^3 c/µL | Standard Error 0.051 |
| Placebo+ Metformin | 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=162, 160, 157, 135) | 0.02 10^3 c/µL | Standard Error 0.051 |
| Placebo+ Metformin | 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=176, 175, 170, 166) | 0.00 10^3 c/µL | Standard Error 0.037 |
| Placebo+ Metformin | 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=91, 88, 88, 50) | -0.21 10^3 c/µL | Standard Error 0.075 |
| Placebo+ Metformin | 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=157, 151, 143, 138) | 0.18 10^3 c/µL | Standard Error 0.047 |
| Placebo+ Metformin | 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=162, 153, 154, 146) | 0.10 10^3 c/µL | Standard Error 0.052 |
| Placebo+ Metformin | 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=61, 48, 63, 31) | -0.32 10^3 c/µL | Standard Error 0.077 |
| Placebo+ Metformin | 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=85, 78, 84, 48) | -0.17 10^3 c/µL | Standard Error 0.08 |
| Placebo+ Metformin | 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=155, 157, 149, 139) | 0.14 10^3 c/µL | Standard Error 0.05 |
| Placebo+ Metformin | 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=166, 166, 157, 137) | 0.04 10^3 c/µL | Standard Error 0.051 |
| Placebo+ Metformin | 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=69, 60, 71, 40) | -0.14 10^3 c/µL | Standard Error 0.079 |
| Placebo+ Metformin | 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=78, 71, 78, 45) | -0.19 10^3 c/µL | Standard Error 0.065 |
| Placebo+ Metformin | 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=156, 152, 145, 136) | 0.11 10^3 c/µL | Standard Error 0.048 |
| Placebo+ Metformin | 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=168, 166, 159, 141) | 0.07 10^3 c/µL | Standard Error 0.045 |
| Placebo+ Metformin | 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=178, 175, 170, 169) | -0.02 10^3 c/µL | Standard Error 0.038 |
| Placebo+ Metformin | 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=77, 67, 75, 42) | -0.13 10^3 c/µL | Standard Error 0.072 |
| Placebo+ Metformin | 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=148, 130, 137, 128) | 0.15 10^3 c/µL | Standard Error 0.046 |
| Placebo+ Metformin | 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=172, 172, 163, 153) | 0.00 10^3 c/µL | Standard Error 0.044 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 2.31 10^3 c/µL | Standard Error 0.054 |
| Placebo+ Metformin | 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=122, 114, 123, 85) | -0.21 10^3 c/µL | Standard Error 0.061 |
| Placebo+ Metformin | 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=134, 126, 130, 94) | -0.17 10^3 c/µL | Standard Error 0.054 |
| Placebo+ Metformin | 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=147, 136, 140, 115) | -0.16 10^3 c/µL | Standard Error 0.051 |
| Placebo+ Metformin | 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=69, 60, 72, 41) | -0.14 10^3 c/µL | Standard Error 0.081 |
| Placebo+ Metformin | 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=104, 104, 111, 68) | -0.20 10^3 c/µL | Standard Error 0.063 |
| Placebo+ Metformin | 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=150, 142, 145, 124) | -0.10 10^3 c/µL | Standard Error 0.042 |
| Placebo+ Metformin | 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=150, 149, 146, 121) | 0.00 10^3 c/µL | Standard Error 0.051 |
| Placebo+ Metformin | 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=175, 172, 165, 158) | -0.03 10^3 c/µL | Standard Error 0.038 |
| Placebo+ Metformin | 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=98, 92, 95, 58) | -0.12 10^3 c/µL | Standard Error 0.065 |
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 + Metformin | Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.40 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 71, 40) | 0.01 10^3 c/µL | Standard Error 0.024 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 142, 145, 124) | 0.04 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 2.5 mg + Metformin | 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=172, 172, 163, 153) | 0.00 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 2.5 mg + Metformin | 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=98, 92, 95, 57) | 0.04 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 2.5 mg + Metformin | 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=147, 136, 140, 115) | 0.06 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 2.5 mg + Metformin | 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=134, 126, 130, 94) | 0.03 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 149, 146, 121) | 0.03 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=104, 104, 111, 68) | 0.02 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 2.5 mg + Metformin | 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=122, 113, 123, 85) | 0.04 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 2.5 mg + Metformin | 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=148, 130, 137, 128) | 0.05 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 72, 41) | 0.02 10^3 c/µL | Standard Error 0.024 |
| Saxagliptin 2.5 mg + Metformin | 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=168, 166, 159, 141) | 0.02 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 2.5 mg + Metformin | 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=61, 48, 63, 31) | 0.00 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 2.5 mg + Metformin | 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=156, 152, 145, 136) | 0.04 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=176, 175, 170, 166) | 0.01 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 2.5 mg + Metformin | 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=76, 67, 75, 42) | 0.01 10^3 c/µL | Standard Error 0.024 |
| Saxagliptin 2.5 mg + Metformin | 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=166, 166, 157, 137) | 0.02 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=155, 157, 149, 139) | 0.06 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=77, 71, 78, 45) | 0.01 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 153, 154, 146) | 0.02 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 2.5 mg + Metformin | 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=157, 151, 143, 138) | 0.06 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=175, 172, 165, 158) | 0.01 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 2.5 mg + Metformin | 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=85, 78, 84, 47) | 0.05 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 160, 157, 135) | 0.03 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=159, 155, 154, 136) | 0.02 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 2.5 mg + Metformin | 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=178, 175, 170, 169) | -0.01 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=90, 87, 88, 50) | 0.04 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 71, 40) | 0.08 10^3 c/µL | Standard Error 0.027 |
| Saxagliptin 5 mg + Metformin | 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=150, 149, 146, 121) | 0.03 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 5 mg + Metformin | 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=156, 152, 145, 136) | 0.03 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 5 mg + Metformin | 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=98, 92, 95, 57) | 0.05 10^3 c/µL | Standard Error 0.023 |
| Saxagliptin 5 mg + Metformin | 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=85, 78, 84, 47) | 0.06 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 5 mg + Metformin | 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=150, 142, 145, 124) | 0.04 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 5 mg + Metformin | 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=162, 160, 157, 135) | 0.02 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 5 mg + Metformin | 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=157, 151, 143, 138) | 0.04 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 5 mg + Metformin | 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=166, 166, 157, 137) | 0.02 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 5 mg + Metformin | 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=147, 136, 140, 115) | 0.06 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 5 mg + Metformin | 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=172, 172, 163, 153) | -0.00 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 5 mg + Metformin | 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=104, 104, 111, 68) | 0.07 10^3 c/µL | Standard Error 0.023 |
| Saxagliptin 5 mg + Metformin | 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=176, 175, 170, 166) | -0.01 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 5 mg + Metformin | 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=134, 126, 130, 94) | 0.05 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 5 mg + Metformin | 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=77, 71, 78, 45) | 0.07 10^3 c/µL | Standard Error 0.025 |
| Saxagliptin 5 mg + Metformin | 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=175, 172, 165, 158) | -0.01 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 5 mg + Metformin | 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=155, 157, 149, 139) | 0.04 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 5 mg + Metformin | 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=122, 113, 123, 85) | 0.04 10^3 c/µL | Standard Error 0.019 |
| Saxagliptin 5 mg + Metformin | 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=178, 175, 170, 169) | -0.01 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 72, 41) | 0.04 10^3 c/µL | Standard Error 0.024 |
| Saxagliptin 5 mg + Metformin | 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=61, 48, 63, 31) | 0.04 10^3 c/µL | Standard Error 0.021 |
| Saxagliptin 5 mg + Metformin | 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=148, 130, 137, 128) | 0.02 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.41 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 5 mg + Metformin | 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=90, 87, 88, 50) | 0.05 10^3 c/µL | Standard Error 0.024 |
| Saxagliptin 5 mg + Metformin | 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=159, 155, 154, 136) | 0.02 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 5 mg + Metformin | 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=168, 166, 159, 141) | 0.01 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 5 mg + Metformin | 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=162, 153, 154, 146) | 0.02 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 5 mg + Metformin | 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=76, 67, 75, 42) | 0.07 10^3 c/µL | Standard Error 0.024 |
| Saxagliptin 10 mg + Metformin | 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=134, 126, 130, 94) | 0.04 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.42 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 10 mg + Metformin | 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=178, 175, 170, 169) | -0.00 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=176, 175, 170, 166) | -0.01 10^3 c/µL | Standard Error 0.013 |
| Saxagliptin 10 mg + Metformin | 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=175, 172, 165, 158) | 0.01 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=172, 172, 163, 153) | -0.02 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | 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=148, 130, 137, 128) | 0.03 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | 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=168, 166, 159, 141) | 0.01 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | 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=156, 152, 145, 136) | 0.03 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 10 mg + Metformin | 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=166, 166, 157, 137) | 0.02 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | 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=155, 157, 149, 139) | 0.05 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 10 mg + Metformin | 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=162, 153, 154, 146) | 0.02 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=157, 151, 143, 138) | 0.03 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | 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=162, 160, 157, 135) | 0.02 10^3 c/µL | Standard Error 0.012 |
| Saxagliptin 10 mg + Metformin | 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=159, 155, 154, 136) | 0.02 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=150, 149, 146, 121) | 0.02 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=150, 142, 145, 124) | 0.04 10^3 c/µL | Standard Error 0.011 |
| Saxagliptin 10 mg + Metformin | 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=147, 136, 140, 115) | 0.06 10^3 c/µL | Standard Error 0.019 |
| Saxagliptin 10 mg + Metformin | 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=122, 113, 123, 85) | 0.06 10^3 c/µL | Standard Error 0.016 |
| Saxagliptin 10 mg + Metformin | 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=104, 104, 111, 68) | 0.03 10^3 c/µL | Standard Error 0.015 |
| Saxagliptin 10 mg + Metformin | 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=98, 92, 95, 57) | 0.08 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 10 mg + Metformin | 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=90, 87, 88, 50) | 0.04 10^3 c/µL | Standard Error 0.014 |
| Saxagliptin 10 mg + Metformin | 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=85, 78, 84, 47) | 0.07 10^3 c/µL | Standard Error 0.018 |
| Saxagliptin 10 mg + Metformin | 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=77, 71, 78, 45) | 0.03 10^3 c/µL | Standard Error 0.019 |
| Saxagliptin 10 mg + Metformin | 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=76, 67, 75, 42) | 0.03 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 72, 41) | 0.06 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 71, 40) | 0.06 10^3 c/µL | Standard Error 0.017 |
| Saxagliptin 10 mg + Metformin | 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=61, 48, 63, 31) | 0.02 10^3 c/µL | Standard Error 0.019 |
| Placebo+ Metformin | 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=159, 155, 154, 136) | 0.05 10^3 c/µL | Standard Error 0.018 |
| Placebo+ Metformin | 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=162, 160, 157, 135) | 0.04 10^3 c/µL | Standard Error 0.013 |
| Placebo+ Metformin | 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=176, 175, 170, 166) | 0.03 10^3 c/µL | Standard Error 0.012 |
| Placebo+ Metformin | 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=90, 87, 88, 50) | 0.04 10^3 c/µL | Standard Error 0.02 |
| Placebo+ Metformin | 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=157, 151, 143, 138) | 0.07 10^3 c/µL | Standard Error 0.013 |
| Placebo+ Metformin | 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=162, 153, 154, 146) | 0.04 10^3 c/µL | Standard Error 0.012 |
| Placebo+ Metformin | 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=61, 48, 63, 31) | 0.01 10^3 c/µL | Standard Error 0.016 |
| Placebo+ Metformin | 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=85, 78, 84, 47) | 0.07 10^3 c/µL | Standard Error 0.019 |
| Placebo+ Metformin | 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=155, 157, 149, 139) | 0.06 10^3 c/µL | Standard Error 0.014 |
| Placebo+ Metformin | 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=166, 166, 157, 137) | 0.03 10^3 c/µL | Standard Error 0.014 |
| Placebo+ Metformin | 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=69, 60, 71, 40) | 0.04 10^3 c/µL | Standard Error 0.014 |
| Placebo+ Metformin | 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=77, 71, 78, 45) | 0.05 10^3 c/µL | Standard Error 0.019 |
| Placebo+ Metformin | 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=156, 152, 145, 136) | 0.05 10^3 c/µL | Standard Error 0.013 |
| Placebo+ Metformin | 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=168, 166, 159, 141) | 0.03 10^3 c/µL | Standard Error 0.014 |
| Placebo+ Metformin | 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=178, 175, 170, 169) | 0.01 10^3 c/µL | Standard Error 0.011 |
| Placebo+ Metformin | 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=76, 67, 75, 42) | 0.05 10^3 c/µL | Standard Error 0.017 |
| Placebo+ Metformin | 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=148, 130, 137, 128) | 0.05 10^3 c/µL | Standard Error 0.014 |
| Placebo+ Metformin | 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=172, 172, 163, 153) | 0.01 10^3 c/µL | Standard Error 0.013 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 0.40 10^3 c/µL | Standard Error 0.014 |
| Placebo+ Metformin | 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=122, 113, 123, 85) | 0.06 10^3 c/µL | Standard Error 0.017 |
| Placebo+ Metformin | 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=134, 126, 130, 94) | 0.05 10^3 c/µL | Standard Error 0.015 |
| Placebo+ Metformin | 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=147, 136, 140, 115) | 0.04 10^3 c/µL | Standard Error 0.015 |
| Placebo+ Metformin | 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=69, 60, 72, 41) | 0.04 10^3 c/µL | Standard Error 0.016 |
| Placebo+ Metformin | 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=104, 104, 111, 68) | 0.06 10^3 c/µL | Standard Error 0.018 |
| Placebo+ Metformin | 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=150, 142, 145, 124) | 0.03 10^3 c/µL | Standard Error 0.013 |
| Placebo+ Metformin | 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=150, 149, 146, 121) | 0.03 10^3 c/µL | Standard Error 0.016 |
| Placebo+ Metformin | 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=175, 172, 165, 158) | 0.02 10^3 c/µL | Standard Error 0.015 |
| Placebo+ Metformin | 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=98, 92, 95, 57) | 0.04 10^3 c/µL | Standard Error 0.019 |
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 + Metformin | Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 4.27 10^3 c/µL | Standard Error 0.101 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 71, 40) | -0.25 10^3 c/µL | Standard Error 0.139 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 142, 145, 124) | -0.03 10^3 c/µL | Standard Error 0.104 |
| Saxagliptin 2.5 mg + Metformin | 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=172, 172, 163, 153) | 0.16 10^3 c/µL | Standard Error 0.087 |
| Saxagliptin 2.5 mg + Metformin | 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=98, 92, 95, 57) | 0.00 10^3 c/µL | Standard Error 0.113 |
| Saxagliptin 2.5 mg + Metformin | 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=147, 136, 140, 115) | -0.05 10^3 c/µL | Standard Error 0.107 |
| Saxagliptin 2.5 mg + Metformin | 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=134, 126, 130, 94) | -0.11 10^3 c/µL | Standard Error 0.108 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 149, 146, 121) | 0.27 10^3 c/µL | Standard Error 0.11 |
| Saxagliptin 2.5 mg + Metformin | 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=104, 104, 111, 68) | -0.16 10^3 c/µL | Standard Error 0.123 |
| Saxagliptin 2.5 mg + Metformin | 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=122, 113, 123, 85) | -0.17 10^3 c/µL | Standard Error 0.121 |
| Saxagliptin 2.5 mg + Metformin | 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=148, 130, 137, 128) | 0.27 10^3 c/µL | Standard Error 0.094 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 72, 41) | -0.23 10^3 c/µL | Standard Error 0.159 |
| Saxagliptin 2.5 mg + Metformin | 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=168, 166, 159, 141) | 0.22 10^3 c/µL | Standard Error 0.085 |
| Saxagliptin 2.5 mg + Metformin | 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=61, 48, 63, 31) | -0.14 10^3 c/µL | Standard Error 0.146 |
| Saxagliptin 2.5 mg + Metformin | 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=156, 152, 145, 136) | 0.38 10^3 c/µL | Standard Error 0.123 |
| Saxagliptin 2.5 mg + Metformin | 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=176, 175, 170, 166) | 0.21 10^3 c/µL | Standard Error 0.097 |
| Saxagliptin 2.5 mg + Metformin | 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=76, 67, 75, 42) | -0.04 10^3 c/µL | Standard Error 0.161 |
| Saxagliptin 2.5 mg + Metformin | 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=166, 166, 157, 137) | 0.24 10^3 c/µL | Standard Error 0.093 |
| Saxagliptin 2.5 mg + Metformin | 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=155, 157, 149, 139) | 0.41 10^3 c/µL | Standard Error 0.104 |
| Saxagliptin 2.5 mg + Metformin | 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=77, 71, 78, 45) | 0.06 10^3 c/µL | Standard Error 0.167 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 153, 154, 146) | 0.17 10^3 c/µL | Standard Error 0.096 |
| Saxagliptin 2.5 mg + Metformin | 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=157, 151, 143, 138) | 0.24 10^3 c/µL | Standard Error 0.096 |
| Saxagliptin 2.5 mg + Metformin | 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=175, 172, 165, 158) | 0.15 10^3 c/µL | Standard Error 0.075 |
| Saxagliptin 2.5 mg + Metformin | 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=85, 78, 84, 47) | 0.00 10^3 c/µL | Standard Error 0.128 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 160, 157, 135) | 0.06 10^3 c/µL | Standard Error 0.088 |
| Saxagliptin 2.5 mg + Metformin | 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=159, 155, 154, 136) | 0.21 10^3 c/µL | Standard Error 0.085 |
| Saxagliptin 2.5 mg + Metformin | 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=178, 175, 170, 169) | 0.15 10^3 c/µL | Standard Error 0.083 |
| Saxagliptin 2.5 mg + Metformin | 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=90, 87, 88, 50) | -0.04 10^3 c/µL | Standard Error 0.147 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 71, 40) | -0.11 10^3 c/µL | Standard Error 0.178 |
| Saxagliptin 5 mg + Metformin | 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=150, 149, 146, 121) | 0.11 10^3 c/µL | Standard Error 0.122 |
| Saxagliptin 5 mg + Metformin | 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=156, 152, 145, 136) | 0.24 10^3 c/µL | Standard Error 0.125 |
| Saxagliptin 5 mg + Metformin | 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=98, 92, 95, 57) | -0.13 10^3 c/µL | Standard Error 0.145 |
| Saxagliptin 5 mg + Metformin | 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=85, 78, 84, 47) | -0.23 10^3 c/µL | Standard Error 0.131 |
| Saxagliptin 5 mg + Metformin | 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=150, 142, 145, 124) | 0.02 10^3 c/µL | Standard Error 0.144 |
| Saxagliptin 5 mg + Metformin | 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=162, 160, 157, 135) | 0.15 10^3 c/µL | Standard Error 0.15 |
| Saxagliptin 5 mg + Metformin | 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=157, 151, 143, 138) | 0.24 10^3 c/µL | Standard Error 0.116 |
| Saxagliptin 5 mg + Metformin | 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=166, 166, 157, 137) | 0.14 10^3 c/µL | Standard Error 0.113 |
| Saxagliptin 5 mg + Metformin | 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=147, 136, 140, 115) | 0.03 10^3 c/µL | Standard Error 0.1 |
| Saxagliptin 5 mg + Metformin | 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=172, 172, 163, 153) | 0.03 10^3 c/µL | Standard Error 0.103 |
| Saxagliptin 5 mg + Metformin | 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=104, 104, 111, 68) | -0.04 10^3 c/µL | Standard Error 0.119 |
| Saxagliptin 5 mg + Metformin | 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=176, 175, 170, 166) | 0.11 10^3 c/µL | Standard Error 0.116 |
| Saxagliptin 5 mg + Metformin | 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=134, 126, 130, 94) | 0.02 10^3 c/µL | Standard Error 0.133 |
| Saxagliptin 5 mg + Metformin | 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=77, 71, 78, 45) | -0.10 10^3 c/µL | Standard Error 0.194 |
| Saxagliptin 5 mg + Metformin | 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=175, 172, 165, 158) | 0.10 10^3 c/µL | Standard Error 0.093 |
| Saxagliptin 5 mg + Metformin | 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=155, 157, 149, 139) | 0.16 10^3 c/µL | Standard Error 0.116 |
| Saxagliptin 5 mg + Metformin | 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=122, 113, 123, 85) | -0.08 10^3 c/µL | Standard Error 0.106 |
| Saxagliptin 5 mg + Metformin | 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=178, 175, 170, 169) | 0.05 10^3 c/µL | Standard Error 0.102 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 72, 41) | -0.35 10^3 c/µL | Standard Error 0.176 |
| Saxagliptin 5 mg + Metformin | 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=61, 48, 63, 31) | -0.40 10^3 c/µL | Standard Error 0.215 |
| Saxagliptin 5 mg + Metformin | 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=148, 130, 137, 128) | 0.28 10^3 c/µL | Standard Error 0.106 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 4.27 10^3 c/µL | Standard Error 0.127 |
| Saxagliptin 5 mg + Metformin | 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=90, 87, 88, 50) | -0.04 10^3 c/µL | Standard Error 0.111 |
| Saxagliptin 5 mg + Metformin | 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=159, 155, 154, 136) | 0.03 10^3 c/µL | Standard Error 0.117 |
| Saxagliptin 5 mg + Metformin | 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=168, 166, 159, 141) | 0.11 10^3 c/µL | Standard Error 0.11 |
| Saxagliptin 5 mg + Metformin | 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=162, 153, 154, 146) | 0.06 10^3 c/µL | Standard Error 0.109 |
| Saxagliptin 5 mg + Metformin | 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=76, 67, 75, 42) | 0.02 10^3 c/µL | Standard Error 0.16 |
| Saxagliptin 10 mg + Metformin | 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=134, 126, 130, 94) | 0.03 10^3 c/µL | Standard Error 0.101 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 4.19 10^3 c/µL | Standard Error 0.105 |
| Saxagliptin 10 mg + Metformin | 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=178, 175, 170, 169) | 0.21 10^3 c/µL | Standard Error 0.087 |
| Saxagliptin 10 mg + Metformin | 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=176, 175, 170, 166) | 0.15 10^3 c/µL | Standard Error 0.09 |
| Saxagliptin 10 mg + Metformin | 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=175, 172, 165, 158) | 0.22 10^3 c/µL | Standard Error 0.085 |
| Saxagliptin 10 mg + Metformin | 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=172, 172, 163, 153) | 0.35 10^3 c/µL | Standard Error 0.096 |
| Saxagliptin 10 mg + Metformin | 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=148, 130, 137, 128) | 0.26 10^3 c/µL | Standard Error 0.093 |
| Saxagliptin 10 mg + Metformin | 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=168, 166, 159, 141) | 0.40 10^3 c/µL | Standard Error 0.102 |
| Saxagliptin 10 mg + Metformin | 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=156, 152, 145, 136) | 0.32 10^3 c/µL | Standard Error 0.109 |
| Saxagliptin 10 mg + Metformin | 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=166, 166, 157, 137) | 0.30 10^3 c/µL | Standard Error 0.107 |
| Saxagliptin 10 mg + Metformin | 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=155, 157, 149, 139) | 0.41 10^3 c/µL | Standard Error 0.099 |
| Saxagliptin 10 mg + Metformin | 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=162, 153, 154, 146) | 0.32 10^3 c/µL | Standard Error 0.099 |
| Saxagliptin 10 mg + Metformin | 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=157, 151, 143, 138) | 0.30 10^3 c/µL | Standard Error 0.097 |
| Saxagliptin 10 mg + Metformin | 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=162, 160, 157, 135) | 0.20 10^3 c/µL | Standard Error 0.091 |
| Saxagliptin 10 mg + Metformin | 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=159, 155, 154, 136) | 0.26 10^3 c/µL | Standard Error 0.09 |
| Saxagliptin 10 mg + Metformin | 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=150, 149, 146, 121) | 0.20 10^3 c/µL | Standard Error 0.096 |
| Saxagliptin 10 mg + Metformin | 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=150, 142, 145, 124) | -0.01 10^3 c/µL | Standard Error 0.107 |
| Saxagliptin 10 mg + Metformin | 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=147, 136, 140, 115) | 0.23 10^3 c/µL | Standard Error 0.14 |
| Saxagliptin 10 mg + Metformin | 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=122, 113, 123, 85) | 0.08 10^3 c/µL | Standard Error 0.132 |
| Saxagliptin 10 mg + Metformin | 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=104, 104, 111, 68) | -0.05 10^3 c/µL | Standard Error 0.093 |
| Saxagliptin 10 mg + Metformin | 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=98, 92, 95, 57) | 0.11 10^3 c/µL | Standard Error 0.167 |
| Saxagliptin 10 mg + Metformin | 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=90, 87, 88, 50) | 0.11 10^3 c/µL | Standard Error 0.136 |
| Saxagliptin 10 mg + Metformin | 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=85, 78, 84, 47) | 0.32 10^3 c/µL | Standard Error 0.151 |
| Saxagliptin 10 mg + Metformin | 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=77, 71, 78, 45) | -0.23 10^3 c/µL | Standard Error 0.117 |
| Saxagliptin 10 mg + Metformin | 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=76, 67, 75, 42) | 0.06 10^3 c/µL | Standard Error 0.13 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 72, 41) | -0.17 10^3 c/µL | Standard Error 0.114 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 71, 40) | 0.11 10^3 c/µL | Standard Error 0.118 |
| Saxagliptin 10 mg + Metformin | 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=61, 48, 63, 31) | -0.03 10^3 c/µL | Standard Error 0.124 |
| Placebo+ Metformin | 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=159, 155, 154, 136) | 0.04 10^3 c/µL | Standard Error 0.111 |
| Placebo+ Metformin | 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=162, 160, 157, 135) | 0.03 10^3 c/µL | Standard Error 0.111 |
| Placebo+ Metformin | 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=176, 175, 170, 166) | 0.19 10^3 c/µL | Standard Error 0.098 |
| Placebo+ Metformin | 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=90, 87, 88, 50) | -0.11 10^3 c/µL | Standard Error 0.185 |
| Placebo+ Metformin | 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=157, 151, 143, 138) | 0.24 10^3 c/µL | Standard Error 0.1 |
| Placebo+ Metformin | 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=162, 153, 154, 146) | 0.24 10^3 c/µL | Standard Error 0.122 |
| Placebo+ Metformin | 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=61, 48, 63, 31) | -0.29 10^3 c/µL | Standard Error 0.154 |
| Placebo+ Metformin | 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=85, 78, 84, 47) | 0.07 10^3 c/µL | Standard Error 0.195 |
| Placebo+ Metformin | 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=155, 157, 149, 139) | 0.34 10^3 c/µL | Standard Error 0.111 |
| Placebo+ Metformin | 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=166, 166, 157, 137) | 0.33 10^3 c/µL | Standard Error 0.113 |
| Placebo+ Metformin | 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=69, 60, 71, 40) | -0.19 10^3 c/µL | Standard Error 0.185 |
| Placebo+ Metformin | 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=77, 71, 78, 45) | -0.34 10^3 c/µL | Standard Error 0.137 |
| Placebo+ Metformin | 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=156, 152, 145, 136) | 0.17 10^3 c/µL | Standard Error 0.112 |
| Placebo+ Metformin | 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=168, 166, 159, 141) | 0.27 10^3 c/µL | Standard Error 0.111 |
| Placebo+ Metformin | 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=178, 175, 170, 169) | 0.12 10^3 c/µL | Standard Error 0.094 |
| Placebo+ Metformin | 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=76, 67, 75, 42) | -0.22 10^3 c/µL | Standard Error 0.145 |
| Placebo+ Metformin | 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=148, 130, 137, 128) | 0.19 10^3 c/µL | Standard Error 0.105 |
| Placebo+ Metformin | 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=172, 172, 163, 153) | 0.02 10^3 c/µL | Standard Error 0.097 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 4.23 10^3 c/µL | Standard Error 0.102 |
| Placebo+ Metformin | 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=122, 113, 123, 85) | -0.18 10^3 c/µL | Standard Error 0.163 |
| Placebo+ Metformin | 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=134, 126, 130, 94) | -0.13 10^3 c/µL | Standard Error 0.146 |
| Placebo+ Metformin | 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=147, 136, 140, 115) | -0.25 10^3 c/µL | Standard Error 0.119 |
| Placebo+ Metformin | 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=69, 60, 72, 41) | -0.20 10^3 c/µL | Standard Error 0.155 |
| Placebo+ Metformin | 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=104, 104, 111, 68) | -0.35 10^3 c/µL | Standard Error 0.142 |
| Placebo+ Metformin | 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=150, 142, 145, 124) | -0.25 10^3 c/µL | Standard Error 0.105 |
| Placebo+ Metformin | 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=150, 149, 146, 121) | 0.08 10^3 c/µL | Standard Error 0.105 |
| Placebo+ Metformin | 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=175, 172, 165, 158) | 0.07 10^3 c/µL | Standard Error 0.098 |
| Placebo+ Metformin | 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=98, 92, 95, 57) | -0.01 10^3 c/µL | Standard Error 0.169 |
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 + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 41.9 percentage red blood cells | Standard Error 0.26 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.7 percentage red blood cells | Standard Error 0.33 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 50 (n=151, 142, 146, 127) | -0.4 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 8 (n=173, 176, 165, 157) | -0.4 percentage red blood cells | Standard Error 0.18 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 115 (n=99, 94, 98, 58) | -0.1 percentage red blood cells | Standard Error 0.22 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 63 (n=148, 137, 142, 116) | 0.1 percentage red blood cells | Standard Error 0.22 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 130, 94) | -0.2 percentage red blood cells | Standard Error 0.25 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 37 (n=152, 149, 146, 122) | -0.1 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 102 (n=108, 104, 112, 70) | -0.7 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 89 (n=123, 114, 123, 85) | -0.2 percentage red blood cells | Standard Error 0.27 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 10 (n=149, 134, 137, 131) | -0.4 percentage red blood cells | Standard Error 0.19 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 180 (n=70, 61, 73, 41) | -1.1 percentage red blood cells | Standard Error 0.32 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 12 (n=170, 167, 160, 144) | -0.1 percentage red blood cells | Standard Error 0.18 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 206 (n=61, 50, 64, 31) | -1.5 percentage red blood cells | Standard Error 0.35 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 14 (n=156, 154, 146, 139) | -0.2 percentage red blood cells | Standard Error 0.18 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 4 (n=178, 178, 174, 166) | -0.3 percentage red blood cells | Standard Error 0.17 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 167 (n=77, 67, 75, 42) | -1.0 percentage red blood cells | Standard Error 0.26 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 16 (n=167, 166, 159, 140) | -0.1 percentage red blood cells | Standard Error 0.2 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 18 (n=155, 158, 149, 141) | -0.3 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 154 (n=81, 74, 78, 45) | -1.5 percentage red blood cells | Standard Error 0.28 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 20 (n=162, 153, 154, 147) | -0.1 percentage red blood cells | Standard Error 0.19 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 22 (n=157, 152, 143, 138) | -0.2 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 6 (n=176, 174, 166, 160) | -0.2 percentage red blood cells | Standard Error 0.17 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 141 (n=85, 79, 85, 48) | -0.6 percentage red blood cells | Standard Error 0.26 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 24 (n=164, 160, 159, 137) | -0.3 percentage red blood cells | Standard Error 0.2 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 30 (n=161, 155, 154, 137) | -0.2 percentage red blood cells | Standard Error 0.19 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 2 (n=181, 177, 172, 169) | -0.3 percentage red blood cells | Standard Error 0.15 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 128 (n=92, 88, 90, 52) | -0.6 percentage red blood cells | Standard Error 0.27 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -1.7 percentage red blood cells | Standard Error 0.46 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 37 (n=152, 149, 146, 122) | -0.4 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 14 (n=156, 154, 146, 139) | -0.2 percentage red blood cells | Standard Error 0.17 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 115 (n=99, 94, 98, 58) | 0.0 percentage red blood cells | Standard Error 0.29 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 141 (n=85, 79, 85, 48) | -0.6 percentage red blood cells | Standard Error 0.28 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 50 (n=151, 142, 146, 127) | -0.5 percentage red blood cells | Standard Error 0.23 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 24 (n=164, 160, 159, 137) | -0.4 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 22 (n=157, 152, 143, 138) | -0.5 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 16 (n=167, 166, 159, 140) | 0.0 percentage red blood cells | Standard Error 0.18 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 63 (n=148, 137, 142, 116) | -0.5 percentage red blood cells | Standard Error 0.28 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 8 (n=173, 176, 165, 157) | -0.1 percentage red blood cells | Standard Error 0.17 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 102 (n=108, 104, 112, 70) | -0.9 percentage red blood cells | Standard Error 0.29 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 4 (n=178, 178, 174, 166) | -0.4 percentage red blood cells | Standard Error 0.15 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 130, 94) | -0.4 percentage red blood cells | Standard Error 0.23 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 154 (n=81, 74, 78, 45) | -1.7 percentage red blood cells | Standard Error 0.3 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 6 (n=176, 174, 166, 160) | -0.3 percentage red blood cells | Standard Error 0.17 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 18 (n=155, 158, 149, 141) | -0.5 percentage red blood cells | Standard Error 0.17 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 89 (n=123, 114, 123, 85) | -0.5 percentage red blood cells | Standard Error 0.25 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 2 (n=181, 177, 172, 169) | -0.5 percentage red blood cells | Standard Error 0.17 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 180 (n=70, 61, 73, 41) | -1.8 percentage red blood cells | Standard Error 0.46 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 206 (n=61, 50, 64, 31) | -2.3 percentage red blood cells | Standard Error 0.41 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 10 (n=149, 134, 137, 131) | -0.4 percentage red blood cells | Standard Error 0.18 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 42.3 percentage red blood cells | Standard Error 0.25 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 128 (n=92, 88, 90, 52) | -0.5 percentage red blood cells | Standard Error 0.32 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 30 (n=161, 155, 154, 137) | -0.4 percentage red blood cells | Standard Error 0.23 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 12 (n=170, 167, 160, 144) | -0.1 percentage red blood cells | Standard Error 0.17 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 20 (n=162, 153, 154, 147) | -0.3 percentage red blood cells | Standard Error 0.19 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 167 (n=77, 67, 75, 42) | -1.6 percentage red blood cells | Standard Error 0.34 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 130, 94) | 0.1 percentage red blood cells | Standard Error 0.22 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 42.2 percentage red blood cells | Standard Error 0.29 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 2 (n=181, 177, 172, 169) | -0.5 percentage red blood cells | Standard Error 0.15 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 4 (n=178, 178, 174, 166) | -0.2 percentage red blood cells | Standard Error 0.18 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 6 (n=176, 174, 166, 160) | -0.1 percentage red blood cells | Standard Error 0.18 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 8 (n=173, 176, 165, 157) | -0.0 percentage red blood cells | Standard Error 0.19 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 10 (n=149, 134, 137, 131) | -0.2 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 12 (n=170, 167, 160, 144) | 0.4 percentage red blood cells | Standard Error 0.19 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 14 (n=156, 154, 146, 139) | -0.1 percentage red blood cells | Standard Error 0.23 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 16 (n=167, 166, 159, 140) | -0.1 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 18 (n=155, 158, 149, 141) | -0.3 percentage red blood cells | Standard Error 0.18 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 20 (n=162, 153, 154, 147) | -0.2 percentage red blood cells | Standard Error 0.2 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 22 (n=157, 152, 143, 138) | -0.5 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 24 (n=164, 160, 159, 137) | -0.3 percentage red blood cells | Standard Error 0.19 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 30 (n=161, 155, 154, 137) | -0.0 percentage red blood cells | Standard Error 0.21 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 37 (n=152, 149, 146, 122) | 0.0 percentage red blood cells | Standard Error 0.23 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 50 (n=151, 142, 146, 127) | -0.1 percentage red blood cells | Standard Error 0.22 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 63 (n=148, 137, 142, 116) | -0.1 percentage red blood cells | Standard Error 0.22 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 89 (n=123, 114, 123, 85) | -0.3 percentage red blood cells | Standard Error 0.27 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 102 (n=108, 104, 112, 70) | -0.2 percentage red blood cells | Standard Error 0.25 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 115 (n=99, 94, 98, 58) | -0.4 percentage red blood cells | Standard Error 0.28 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 128 (n=92, 88, 90, 52) | -0.5 percentage red blood cells | Standard Error 0.28 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 141 (n=85, 79, 85, 48) | -0.3 percentage red blood cells | Standard Error 0.31 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 154 (n=81, 74, 78, 45) | -1.2 percentage red blood cells | Standard Error 0.32 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 167 (n=77, 67, 75, 42) | -1.2 percentage red blood cells | Standard Error 0.36 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 180 (n=70, 61, 73, 41) | -0.7 percentage red blood cells | Standard Error 0.3 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.5 percentage red blood cells | Standard Error 0.33 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 206 (n=61, 50, 64, 31) | -0.7 percentage red blood cells | Standard Error 0.32 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 30 (n=161, 155, 154, 137) | -0.2 percentage red blood cells | Standard Error 0.23 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 24 (n=164, 160, 159, 137) | -0.4 percentage red blood cells | Standard Error 0.22 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 4 (n=178, 178, 174, 166) | -0.0 percentage red blood cells | Standard Error 0.17 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 128 (n=92, 88, 90, 52) | -0.5 percentage red blood cells | Standard Error 0.34 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 22 (n=157, 152, 143, 138) | -0.5 percentage red blood cells | Standard Error 0.23 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 20 (n=162, 153, 154, 147) | -0.3 percentage red blood cells | Standard Error 0.2 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 206 (n=61, 50, 64, 31) | -1.3 percentage red blood cells | Standard Error 0.48 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 141 (n=85, 79, 85, 48) | -0.9 percentage red blood cells | Standard Error 0.37 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 18 (n=155, 158, 149, 141) | -0.1 percentage red blood cells | Standard Error 0.21 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 16 (n=167, 166, 159, 140) | 0.2 percentage red blood cells | Standard Error 0.19 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.7 percentage red blood cells | Standard Error 0.42 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 154 (n=81, 74, 78, 45) | -1.6 percentage red blood cells | Standard Error 0.34 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 14 (n=156, 154, 146, 139) | 0.0 percentage red blood cells | Standard Error 0.2 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 12 (n=170, 167, 160, 144) | 0.0 percentage red blood cells | Standard Error 0.2 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 2 (n=181, 177, 172, 169) | -0.4 percentage red blood cells | Standard Error 0.15 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 167 (n=77, 67, 75, 42) | -1.1 percentage red blood cells | Standard Error 0.41 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 10 (n=149, 134, 137, 131) | -0.1 percentage red blood cells | Standard Error 0.2 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 8 (n=173, 176, 165, 157) | -0.0 percentage red blood cells | Standard Error 0.19 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 41.8 percentage red blood cells | Standard Error 0.28 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 89 (n=123, 114, 123, 85) | -0.3 percentage red blood cells | Standard Error 0.29 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 130, 94) | -0.4 percentage red blood cells | Standard Error 0.28 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 63 (n=148, 137, 142, 116) | -0.0 percentage red blood cells | Standard Error 0.24 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 180 (n=70, 61, 73, 41) | -1.2 percentage red blood cells | Standard Error 0.34 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 102 (n=108, 104, 112, 70) | -0.7 percentage red blood cells | Standard Error 0.31 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 50 (n=151, 142, 146, 127) | -0.0 percentage red blood cells | Standard Error 0.25 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 37 (n=152, 149, 146, 122) | -0.1 percentage red blood cells | Standard Error 0.21 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 6 (n=176, 174, 166, 160) | -0.0 percentage red blood cells | Standard Error 0.17 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | Change from BL at Week 115 (n=99, 94, 98, 58) | -0.2 percentage red blood cells | Standard Error 0.33 |
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 + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Baseline (BL) (Week 0) (n=192, 191, 181, 179) | 14.06 g/dL | Standard Error 0.098 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.60 g/dL | Standard Error 0.103 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 50 (n=151, 142, 146, 127) | -0.22 g/dL | Standard Error 0.061 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 8 (n=173, 176, 165, 157) | -0.07 g/dL | Standard Error 0.058 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 115 (n=99, 94, 98, 58) | -0.26 g/dL | Standard Error 0.073 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 63 (n=148, 137, 142, 116) | -0.10 g/dL | Standard Error 0.068 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 130, 94) | -0.27 g/dL | Standard Error 0.077 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 37 (n=152, 149, 146, 122) | -0.17 g/dL | Standard Error 0.068 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 102 (n=108, 104, 112, 70) | -0.36 g/dL | Standard Error 0.073 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 89 (n=123, 114, 123, 85) | -0.22 g/dL | Standard Error 0.074 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 10 (n=149, 134, 137, 131) | -0.16 g/dL | Standard Error 0.061 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 180 (n=70, 61, 73, 41) | -0.62 g/dL | Standard Error 0.099 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 12 (n=170, 167, 160, 144) | -0.05 g/dL | Standard Error 0.059 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 206 (n=61, 50, 64, 31) | -0.62 g/dL | Standard Error 0.108 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 14 (n=156, 154, 146, 139) | -0.15 g/dL | Standard Error 0.059 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 4 (n=178, 178, 174, 166) | -0.07 g/dL | Standard Error 0.052 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 167 (n=77, 67, 75, 42) | -0.49 g/dL | Standard Error 0.085 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 16 (n=167, 166, 159, 140) | -0.12 g/dL | Standard Error 0.059 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 18 (n=155, 158, 149, 141) | -0.24 g/dL | Standard Error 0.069 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 154 (n=81, 74, 78, 45) | -0.59 g/dL | Standard Error 0.092 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 20 (n=162, 153, 154, 147) | -0.16 g/dL | Standard Error 0.059 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 22 (n=157, 152, 143, 138) | -0.21 g/dL | Standard Error 0.064 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 6 (n=176, 174, 166, 160) | -0.06 g/dL | Standard Error 0.052 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 141 (n=85, 79, 85, 48) | -0.49 g/dL | Standard Error 0.091 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 24 (n=164, 160, 159, 137) | -0.23 g/dL | Standard Error 0.064 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 30 (n=161, 155, 154, 137) | -0.19 g/dL | Standard Error 0.059 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 2 (n=181, 177, 172, 169) | -0.08 g/dL | Standard Error 0.044 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 128 (n=92, 88, 90, 52) | -0.40 g/dL | Standard Error 0.095 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.82 g/dL | Standard Error 0.159 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 37 (n=152, 149, 146, 122) | -0.29 g/dL | Standard Error 0.064 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 14 (n=156, 154, 146, 139) | -0.20 g/dL | Standard Error 0.055 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 115 (n=99, 94, 98, 58) | -0.26 g/dL | Standard Error 0.082 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 141 (n=85, 79, 85, 48) | -0.45 g/dL | Standard Error 0.093 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 50 (n=151, 142, 146, 127) | -0.22 g/dL | Standard Error 0.07 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 24 (n=164, 160, 159, 137) | -0.30 g/dL | Standard Error 0.063 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 22 (n=157, 152, 143, 138) | -0.33 g/dL | Standard Error 0.063 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 16 (n=167, 166, 159, 140) | -0.13 g/dL | Standard Error 0.052 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 63 (n=148, 137, 142, 116) | -0.28 g/dL | Standard Error 0.096 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 8 (n=173, 176, 165, 157) | -0.07 g/dL | Standard Error 0.051 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 102 (n=108, 104, 112, 70) | -0.40 g/dL | Standard Error 0.085 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 4 (n=178, 178, 174, 166) | -0.15 g/dL | Standard Error 0.047 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 130, 94) | -0.31 g/dL | Standard Error 0.08 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 154 (n=81, 74, 78, 45) | -0.56 g/dL | Standard Error 0.105 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 6 (n=176, 174, 166, 160) | -0.15 g/dL | Standard Error 0.05 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 18 (n=155, 158, 149, 141) | -0.28 g/dL | Standard Error 0.05 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 89 (n=123, 114, 123, 85) | -0.38 g/dL | Standard Error 0.075 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 2 (n=181, 177, 172, 169) | -0.18 g/dL | Standard Error 0.052 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 180 (n=70, 61, 73, 41) | -0.81 g/dL | Standard Error 0.154 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 206 (n=61, 50, 64, 31) | -0.87 g/dL | Standard Error 0.135 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 10 (n=149, 134, 137, 131) | -0.17 g/dL | Standard Error 0.057 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Baseline (BL) (Week 0) (n=192, 191, 181, 179) | 14.18 g/dL | Standard Error 0.094 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 128 (n=92, 88, 90, 52) | -0.41 g/dL | Standard Error 0.097 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 30 (n=161, 155, 154, 137) | -0.29 g/dL | Standard Error 0.063 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 12 (n=170, 167, 160, 144) | -0.11 g/dL | Standard Error 0.054 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 20 (n=162, 153, 154, 147) | -0.23 g/dL | Standard Error 0.061 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 167 (n=77, 67, 75, 42) | -0.58 g/dL | Standard Error 0.127 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 130, 94) | -0.26 g/dL | Standard Error 0.066 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Baseline (BL) (Week 0) (n=192, 191, 181, 179) | 14.18 g/dL | Standard Error 0.103 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 2 (n=181, 177, 172, 169) | -0.18 g/dL | Standard Error 0.044 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 4 (n=178, 178, 174, 166) | -0.09 g/dL | Standard Error 0.053 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 6 (n=176, 174, 166, 160) | -0.07 g/dL | Standard Error 0.05 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 8 (n=173, 176, 165, 157) | -0.02 g/dL | Standard Error 0.055 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 10 (n=149, 134, 137, 131) | -0.16 g/dL | Standard Error 0.067 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 12 (n=170, 167, 160, 144) | 0.03 g/dL | Standard Error 0.055 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 14 (n=156, 154, 146, 139) | -0.10 g/dL | Standard Error 0.068 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 16 (n=167, 166, 159, 140) | -0.10 g/dL | Standard Error 0.06 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 18 (n=155, 158, 149, 141) | -0.19 g/dL | Standard Error 0.059 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 20 (n=162, 153, 154, 147) | -0.10 g/dL | Standard Error 0.06 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 22 (n=157, 152, 143, 138) | -0.25 g/dL | Standard Error 0.062 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 24 (n=164, 160, 159, 137) | -0.25 g/dL | Standard Error 0.057 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 30 (n=161, 155, 154, 137) | -0.22 g/dL | Standard Error 0.071 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 37 (n=152, 149, 146, 122) | -0.19 g/dL | Standard Error 0.067 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 50 (n=151, 142, 146, 127) | -0.13 g/dL | Standard Error 0.066 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 63 (n=148, 137, 142, 116) | -0.17 g/dL | Standard Error 0.067 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 89 (n=123, 114, 123, 85) | -0.32 g/dL | Standard Error 0.083 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 102 (n=108, 104, 112, 70) | -0.27 g/dL | Standard Error 0.078 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 115 (n=99, 94, 98, 58) | -0.36 g/dL | Standard Error 0.092 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 128 (n=92, 88, 90, 52) | -0.39 g/dL | Standard Error 0.095 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 141 (n=85, 79, 85, 48) | -0.42 g/dL | Standard Error 0.104 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 154 (n=81, 74, 78, 45) | -0.47 g/dL | Standard Error 0.102 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 167 (n=77, 67, 75, 42) | -0.53 g/dL | Standard Error 0.119 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 180 (n=70, 61, 73, 41) | -0.46 g/dL | Standard Error 0.107 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.47 g/dL | Standard Error 0.101 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 206 (n=61, 50, 64, 31) | -0.49 g/dL | Standard Error 0.101 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 30 (n=161, 155, 154, 137) | -0.18 g/dL | Standard Error 0.065 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 24 (n=164, 160, 159, 137) | -0.24 g/dL | Standard Error 0.065 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 4 (n=178, 178, 174, 166) | 0.03 g/dL | Standard Error 0.056 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 128 (n=92, 88, 90, 52) | -0.28 g/dL | Standard Error 0.105 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 22 (n=157, 152, 143, 138) | -0.23 g/dL | Standard Error 0.065 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 20 (n=162, 153, 154, 147) | -0.12 g/dL | Standard Error 0.06 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 206 (n=61, 50, 64, 31) | -0.75 g/dL | Standard Error 0.125 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 141 (n=85, 79, 85, 48) | -0.45 g/dL | Standard Error 0.132 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 18 (n=155, 158, 149, 141) | -0.09 g/dL | Standard Error 0.062 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 16 (n=167, 166, 159, 140) | -0.01 g/dL | Standard Error 0.06 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.53 g/dL | Standard Error 0.134 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 154 (n=81, 74, 78, 45) | -0.57 g/dL | Standard Error 0.107 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 14 (n=156, 154, 146, 139) | -0.02 g/dL | Standard Error 0.066 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 12 (n=170, 167, 160, 144) | -0.05 g/dL | Standard Error 0.065 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 2 (n=181, 177, 172, 169) | -0.09 g/dL | Standard Error 0.046 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 167 (n=77, 67, 75, 42) | -0.51 g/dL | Standard Error 0.137 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 10 (n=149, 134, 137, 131) | -0.16 g/dL | Standard Error 0.064 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 8 (n=173, 176, 165, 157) | 0.01 g/dL | Standard Error 0.056 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Baseline (BL) (Week 0) (n=192, 191, 181, 179) | 13.99 g/dL | Standard Error 0.096 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 89 (n=123, 114, 123, 85) | -0.25 g/dL | Standard Error 0.088 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 130, 94) | -0.26 g/dL | Standard Error 0.083 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 63 (n=148, 137, 142, 116) | -0.07 g/dL | Standard Error 0.073 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 180 (n=70, 61, 73, 41) | -0.53 g/dL | Standard Error 0.129 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 102 (n=108, 104, 112, 70) | -0.34 g/dL | Standard Error 0.1 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 50 (n=151, 142, 146, 127) | -0.12 g/dL | Standard Error 0.077 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 37 (n=152, 149, 146, 122) | -0.17 g/dL | Standard Error 0.066 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 6 (n=176, 174, 166, 160) | 0.00 g/dL | Standard Error 0.055 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | Change from BL at Week 115 (n=99, 94, 98, 58) | -0.26 g/dL | Standard Error 0.106 |
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 + Metformin | Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period | Baseline (Week 0) (n=192, 189, 181, 178) | 265.5 10^9 c/L | Standard Error 4.78 |
| Saxagliptin 2.5 mg + Metformin | 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=67, 57, 68, 40) | 1.3 10^9 c/L | Standard Error 6.4 |
| Saxagliptin 2.5 mg + Metformin | 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=151, 141, 143, 120) | -3.2 10^9 c/L | Standard Error 3.4 |
| Saxagliptin 2.5 mg + Metformin | 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=172, 170, 162, 151) | 6.7 10^9 c/L | Standard Error 2.53 |
| Saxagliptin 2.5 mg + Metformin | 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=99, 93, 98, 57) | 1.1 10^9 c/L | Standard Error 4.45 |
| Saxagliptin 2.5 mg + Metformin | 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=147, 132, 137, 115) | 2.6 10^9 c/L | Standard Error 3.24 |
| Saxagliptin 2.5 mg + Metformin | 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=132, 124, 130, 92) | 0.1 10^9 c/L | Standard Error 3.84 |
| Saxagliptin 2.5 mg + Metformin | 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=149, 142, 139, 120) | -2.6 10^9 c/L | Standard Error 3.07 |
| Saxagliptin 2.5 mg + Metformin | 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=107, 103, 110, 69) | 0.3 10^9 c/L | Standard Error 3.96 |
| Saxagliptin 2.5 mg + Metformin | 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=122, 111, 122, 84) | 9.1 10^9 c/L | Standard Error 4.42 |
| Saxagliptin 2.5 mg + Metformin | 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=147, 132, 137, 129) | 4.7 10^9 c/L | Standard Error 2.73 |
| Saxagliptin 2.5 mg + Metformin | 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=68, 60, 71, 41) | -2.7 10^9 c/L | Standard Error 6.19 |
| Saxagliptin 2.5 mg + Metformin | 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=170, 165, 157, 141) | 6.8 10^9 c/L | Standard Error 2.49 |
| Saxagliptin 2.5 mg + Metformin | 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=61, 49, 64, 31) | -0.7 10^9 c/L | Standard Error 6.45 |
| Saxagliptin 2.5 mg + Metformin | 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=153, 149, 145, 133) | 6.1 10^9 c/L | Standard Error 3.16 |
| Saxagliptin 2.5 mg + Metformin | 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=176, 172, 168, 164) | 11.3 10^9 c/L | Standard Error 2.59 |
| Saxagliptin 2.5 mg + Metformin | 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=75, 64, 74, 41) | 10.1 10^9 c/L | Standard Error 5.39 |
| Saxagliptin 2.5 mg + Metformin | 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=166, 161, 156, 133) | 5.3 10^9 c/L | Standard Error 2.71 |
| Saxagliptin 2.5 mg + Metformin | 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=152, 155, 147, 139) | 5.6 10^9 c/L | Standard Error 2.95 |
| Saxagliptin 2.5 mg + Metformin | 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=79, 70, 77, 45) | 8.0 10^9 c/L | Standard Error 5.65 |
| Saxagliptin 2.5 mg + Metformin | 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=160, 151, 153, 144) | 4.9 10^9 c/L | Standard Error 3 |
| Saxagliptin 2.5 mg + Metformin | 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=151, 148, 142, 134) | 3.5 10^9 c/L | Standard Error 2.5 |
| Saxagliptin 2.5 mg + Metformin | 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=171, 171, 164, 157) | 8.7 10^9 c/L | Standard Error 2.46 |
| Saxagliptin 2.5 mg + Metformin | 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=83, 77, 84, 47) | 9.2 10^9 c/L | Standard Error 4.96 |
| Saxagliptin 2.5 mg + Metformin | 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=158, 153, 156, 135) | 0.6 10^9 c/L | Standard Error 2.97 |
| Saxagliptin 2.5 mg + Metformin | 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=157, 153, 148, 130) | -0.1 10^9 c/L | Standard Error 2.96 |
| Saxagliptin 2.5 mg + Metformin | 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=179, 168, 167, 166) | 8.4 10^9 c/L | Standard Error 2.32 |
| Saxagliptin 2.5 mg + Metformin | 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=91, 84, 88, 51) | 5.7 10^9 c/L | Standard Error 5.27 |
| Saxagliptin 5 mg + Metformin | 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=67, 57, 68, 40) | -2.9 10^9 c/L | Standard Error 5.4 |
| Saxagliptin 5 mg + Metformin | 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=149, 142, 139, 120) | -4.1 10^9 c/L | Standard Error 3.16 |
| Saxagliptin 5 mg + Metformin | 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=153, 149, 145, 133) | 7.4 10^9 c/L | Standard Error 2.7 |
| Saxagliptin 5 mg + Metformin | 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=99, 93, 98, 57) | 4.2 10^9 c/L | Standard Error 4.12 |
| Saxagliptin 5 mg + Metformin | 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=83, 77, 84, 47) | 6.5 10^9 c/L | Standard Error 4.45 |
| Saxagliptin 5 mg + Metformin | 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=151, 141, 143, 120) | -2.4 10^9 c/L | Standard Error 3.44 |
| Saxagliptin 5 mg + Metformin | 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=158, 153, 156, 135) | 3.5 10^9 c/L | Standard Error 2.77 |
| Saxagliptin 5 mg + Metformin | 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=151, 148, 142, 134) | 9.7 10^9 c/L | Standard Error 2.98 |
| Saxagliptin 5 mg + Metformin | 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=166, 161, 156, 133) | 7.1 10^9 c/L | Standard Error 2.76 |
| Saxagliptin 5 mg + Metformin | 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=147, 132, 137, 115) | 3.5 10^9 c/L | Standard Error 3.36 |
| Saxagliptin 5 mg + Metformin | 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=172, 170, 162, 151) | 7.5 10^9 c/L | Standard Error 2.47 |
| Saxagliptin 5 mg + Metformin | 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=107, 103, 110, 69) | 6.1 10^9 c/L | Standard Error 3.47 |
| Saxagliptin 5 mg + Metformin | 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=176, 172, 168, 164) | 11.8 10^9 c/L | Standard Error 2.55 |
| Saxagliptin 5 mg + Metformin | 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=132, 124, 130, 92) | 4.0 10^9 c/L | Standard Error 3.55 |
| Saxagliptin 5 mg + Metformin | 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=79, 70, 77, 45) | 9.4 10^9 c/L | Standard Error 4.55 |
| Saxagliptin 5 mg + Metformin | 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=171, 171, 164, 157) | 8.5 10^9 c/L | Standard Error 2.78 |
| Saxagliptin 5 mg + Metformin | 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=152, 155, 147, 139) | 3.0 10^9 c/L | Standard Error 2.66 |
| Saxagliptin 5 mg + Metformin | 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=122, 111, 122, 84) | 8.6 10^9 c/L | Standard Error 3.01 |
| Saxagliptin 5 mg + Metformin | 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=179, 168, 167, 166) | 9.8 10^9 c/L | Standard Error 2.77 |
| Saxagliptin 5 mg + Metformin | 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=68, 60, 71, 41) | -1.2 10^9 c/L | Standard Error 5.65 |
| Saxagliptin 5 mg + Metformin | 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=61, 49, 64, 31) | 1.5 10^9 c/L | Standard Error 7.48 |
| Saxagliptin 5 mg + Metformin | 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=147, 132, 137, 129) | 8.5 10^9 c/L | Standard Error 3.23 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period | Baseline (Week 0) (n=192, 189, 181, 178) | 256.2 10^9 c/L | Standard Error 4.28 |
| Saxagliptin 5 mg + Metformin | 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=91, 84, 88, 51) | 3.2 10^9 c/L | Standard Error 3.89 |
| Saxagliptin 5 mg + Metformin | 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=157, 153, 148, 130) | 3.6 10^9 c/L | Standard Error 2.88 |
| Saxagliptin 5 mg + Metformin | 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=170, 165, 157, 141) | 9.3 10^9 c/L | Standard Error 3.26 |
| Saxagliptin 5 mg + Metformin | 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=160, 151, 153, 144) | 7.0 10^9 c/L | Standard Error 3.07 |
| Saxagliptin 5 mg + Metformin | 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=75, 64, 74, 41) | 3.2 10^9 c/L | Standard Error 4.39 |
| Saxagliptin 10 mg + Metformin | 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=132, 124, 130, 92) | -2.6 10^9 c/L | Standard Error 3.09 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period | Baseline (Week 0) (n=192, 189, 181, 178) | 258.7 10^9 c/L | Standard Error 5.05 |
| Saxagliptin 10 mg + Metformin | 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=179, 168, 167, 166) | 6.5 10^9 c/L | Standard Error 2.57 |
| Saxagliptin 10 mg + Metformin | 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=176, 172, 168, 164) | 5.1 10^9 c/L | Standard Error 2.31 |
| Saxagliptin 10 mg + Metformin | 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=171, 171, 164, 157) | 5.1 10^9 c/L | Standard Error 4.16 |
| Saxagliptin 10 mg + Metformin | 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=172, 170, 162, 151) | 4.9 10^9 c/L | Standard Error 2.67 |
| Saxagliptin 10 mg + Metformin | 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=147, 132, 137, 129) | 0.5 10^9 c/L | Standard Error 3.24 |
| Saxagliptin 10 mg + Metformin | 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=170, 165, 157, 141) | 4.8 10^9 c/L | Standard Error 3.24 |
| Saxagliptin 10 mg + Metformin | 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=153, 149, 145, 133) | 2.5 10^9 c/L | Standard Error 3.08 |
| Saxagliptin 10 mg + Metformin | 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=166, 161, 156, 133) | -0.0 10^9 c/L | Standard Error 2.64 |
| Saxagliptin 10 mg + Metformin | 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=152, 155, 147, 139) | 5.2 10^9 c/L | Standard Error 2.82 |
| Saxagliptin 10 mg + Metformin | 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=160, 151, 153, 144) | -1.7 10^9 c/L | Standard Error 2.64 |
| Saxagliptin 10 mg + Metformin | 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=151, 148, 142, 134) | -1.7 10^9 c/L | Standard Error 2.95 |
| Saxagliptin 10 mg + Metformin | 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=158, 153, 156, 135) | -2.0 10^9 c/L | Standard Error 2.75 |
| Saxagliptin 10 mg + Metformin | 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=157, 153, 148, 130) | -0.8 10^9 c/L | Standard Error 3.18 |
| Saxagliptin 10 mg + Metformin | 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=149, 142, 139, 120) | -11.9 10^9 c/L | Standard Error 2.98 |
| Saxagliptin 10 mg + Metformin | 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=151, 141, 143, 120) | -9.0 10^9 c/L | Standard Error 3.13 |
| Saxagliptin 10 mg + Metformin | 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=147, 132, 137, 115) | 0.1 10^9 c/L | Standard Error 4.8 |
| Saxagliptin 10 mg + Metformin | 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=122, 111, 122, 84) | 1.4 10^9 c/L | Standard Error 3.68 |
| Saxagliptin 10 mg + Metformin | 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=107, 103, 110, 69) | 3.3 10^9 c/L | Standard Error 3.74 |
| Saxagliptin 10 mg + Metformin | 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=99, 93, 98, 57) | 1.2 10^9 c/L | Standard Error 4.19 |
| Saxagliptin 10 mg + Metformin | 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=91, 84, 88, 51) | 2.2 10^9 c/L | Standard Error 4.41 |
| Saxagliptin 10 mg + Metformin | 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=83, 77, 84, 47) | 1.1 10^9 c/L | Standard Error 5.21 |
| Saxagliptin 10 mg + Metformin | 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=79, 70, 77, 45) | -1.8 10^9 c/L | Standard Error 5.79 |
| Saxagliptin 10 mg + Metformin | 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=75, 64, 74, 41) | -1.9 10^9 c/L | Standard Error 5.26 |
| Saxagliptin 10 mg + Metformin | 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=68, 60, 71, 41) | -8.3 10^9 c/L | Standard Error 5.07 |
| Saxagliptin 10 mg + Metformin | 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=67, 57, 68, 40) | -8.5 10^9 c/L | Standard Error 5.19 |
| Saxagliptin 10 mg + Metformin | 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=61, 49, 64, 31) | -4.7 10^9 c/L | Standard Error 5.62 |
| Placebo+ Metformin | 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=157, 153, 148, 130) | 2.0 10^9 c/L | Standard Error 3.65 |
| Placebo+ Metformin | 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=158, 153, 156, 135) | -2.3 10^9 c/L | Standard Error 2.95 |
| Placebo+ Metformin | 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=176, 172, 168, 164) | 11.1 10^9 c/L | Standard Error 3.04 |
| Placebo+ Metformin | 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=91, 84, 88, 51) | 4.5 10^9 c/L | Standard Error 4.73 |
| Placebo+ Metformin | 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=151, 148, 142, 134) | 4.1 10^9 c/L | Standard Error 3.24 |
| Placebo+ Metformin | 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=160, 151, 153, 144) | 6.8 10^9 c/L | Standard Error 3.06 |
| Placebo+ Metformin | 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=61, 49, 64, 31) | 9.8 10^9 c/L | Standard Error 7.45 |
| Placebo+ Metformin | 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=83, 77, 84, 47) | 12.0 10^9 c/L | Standard Error 5.24 |
| Placebo+ Metformin | 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=152, 155, 147, 139) | 8.5 10^9 c/L | Standard Error 3.59 |
| Placebo+ Metformin | 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=166, 161, 156, 133) | 7.4 10^9 c/L | Standard Error 3.15 |
| Placebo+ Metformin | 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=67, 57, 68, 40) | 12.2 10^9 c/L | Standard Error 6.79 |
| Placebo+ Metformin | 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=79, 70, 77, 45) | 12.5 10^9 c/L | Standard Error 7.01 |
| Placebo+ Metformin | 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=153, 149, 145, 133) | 7.5 10^9 c/L | Standard Error 2.7 |
| Placebo+ Metformin | 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=170, 165, 157, 141) | 8.2 10^9 c/L | Standard Error 2.83 |
| Placebo+ Metformin | 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=179, 168, 167, 166) | 13.7 10^9 c/L | Standard Error 2.99 |
| Placebo+ Metformin | 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=75, 64, 74, 41) | 13.8 10^9 c/L | Standard Error 6.78 |
| Placebo+ Metformin | 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=147, 132, 137, 129) | 11.5 10^9 c/L | Standard Error 3.3 |
| Placebo+ Metformin | 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=172, 170, 162, 151) | 8.5 10^9 c/L | Standard Error 3.07 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period | Baseline (Week 0) (n=192, 189, 181, 178) | 261.0 10^9 c/L | Standard Error 5.05 |
| Placebo+ Metformin | 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=122, 111, 122, 84) | 13.6 10^9 c/L | Standard Error 3.91 |
| Placebo+ Metformin | 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=132, 124, 130, 92) | 4.7 10^9 c/L | Standard Error 3.98 |
| Placebo+ Metformin | 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=147, 132, 137, 115) | -4.7 10^9 c/L | Standard Error 4.15 |
| Placebo+ Metformin | 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=68, 60, 71, 41) | 8.9 10^9 c/L | Standard Error 5.8 |
| Placebo+ Metformin | 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=107, 103, 110, 69) | 6.1 10^9 c/L | Standard Error 5.2 |
| Placebo+ Metformin | 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=151, 141, 143, 120) | -6.4 10^9 c/L | Standard Error 3.7 |
| Placebo+ Metformin | 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=149, 142, 139, 120) | -2.3 10^9 c/L | Standard Error 3.84 |
| Placebo+ Metformin | 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=171, 171, 164, 157) | 12.0 10^9 c/L | Standard Error 2.99 |
| Placebo+ Metformin | 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=99, 93, 98, 57) | 7.0 10^9 c/L | Standard Error 5.12 |
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 + Metformin | 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=156, 154, 146, 139) | 0.01 10^6 c/µL | Standard Error 0.019 |
| Saxagliptin 2.5 mg + Metformin | 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=123, 114, 123, 85) | -0.09 10^6 c/µL | Standard Error 0.027 |
| Saxagliptin 2.5 mg + Metformin | 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=178, 178, 174, 166) | -0.02 10^6 c/µL | Standard Error 0.018 |
| Saxagliptin 2.5 mg + Metformin | 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=173, 176, 165, 157) | 0.00 10^6 c/µL | Standard Error 0.019 |
| Saxagliptin 2.5 mg + Metformin | 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=167, 166, 159, 140) | 0.04 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 2.5 mg + Metformin | 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=70, 60, 72, 40) | -0.14 10^6 c/µL | Standard Error 0.035 |
| Saxagliptin 2.5 mg + Metformin | 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=108, 104, 112, 70) | -0.13 10^6 c/µL | Standard Error 0.024 |
| Saxagliptin 2.5 mg + Metformin | 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=77, 67, 75, 42) | -0.14 10^6 c/µL | Standard Error 0.03 |
| Saxagliptin 2.5 mg + Metformin | 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=155, 158, 149, 141) | 0.00 10^6 c/µL | Standard Error 0.024 |
| Saxagliptin 2.5 mg + Metformin | 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=149, 134, 137, 131) | -0.03 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 2.5 mg + Metformin | Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 4.68 10^6 c/µL | Standard Error 0.031 |
| Saxagliptin 2.5 mg + Metformin | 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=99, 94, 98, 58) | -0.08 10^6 c/µL | Standard Error 0.024 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 153, 154, 147) | 0.02 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 2.5 mg + Metformin | 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=134, 126, 130, 94) | -0.08 10^6 c/µL | Standard Error 0.025 |
| Saxagliptin 2.5 mg + Metformin | 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=61, 50, 64, 31) | -0.16 10^6 c/µL | Standard Error 0.04 |
| Saxagliptin 2.5 mg + Metformin | 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=81, 74, 78, 45) | -0.19 10^6 c/µL | Standard Error 0.032 |
| Saxagliptin 2.5 mg + Metformin | 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=157, 152, 143, 138) | 0.00 10^6 c/µL | Standard Error 0.022 |
| Saxagliptin 2.5 mg + Metformin | 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=151, 142, 146, 127) | -0.06 10^6 c/µL | Standard Error 0.022 |
| Saxagliptin 2.5 mg + Metformin | 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=176, 174, 166, 160) | -0.01 10^6 c/µL | Standard Error 0.017 |
| Saxagliptin 2.5 mg + Metformin | 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=170, 167, 160, 144) | 0.03 10^6 c/µL | Standard Error 0.019 |
| Saxagliptin 2.5 mg + Metformin | 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=164, 160, 159, 137) | -0.02 10^6 c/µL | Standard Error 0.022 |
| Saxagliptin 2.5 mg + Metformin | 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=148, 137, 142, 116) | -0.01 10^6 c/µL | Standard Error 0.022 |
| Saxagliptin 2.5 mg + Metformin | 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=92, 88, 90, 52) | -0.10 10^6 c/µL | Standard Error 0.028 |
| Saxagliptin 2.5 mg + Metformin | 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=85, 79, 85, 48) | -0.13 10^6 c/µL | Standard Error 0.03 |
| Saxagliptin 2.5 mg + Metformin | 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=161, 155, 154, 137) | -0.01 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 2.5 mg + Metformin | 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=70, 61, 73, 41) | -0.16 10^6 c/µL | Standard Error 0.033 |
| Saxagliptin 2.5 mg + Metformin | 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=181, 177, 172, 169) | -0.04 10^6 c/µL | Standard Error 0.015 |
| Saxagliptin 2.5 mg + Metformin | 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=152, 149, 146, 122) | -0.00 10^6 c/µL | Standard Error 0.023 |
| Saxagliptin 5 mg + Metformin | 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=92, 88, 90, 52) | -0.07 10^6 c/µL | Standard Error 0.03 |
| Saxagliptin 5 mg + Metformin | 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=152, 149, 146, 122) | -0.01 10^6 c/µL | Standard Error 0.019 |
| Saxagliptin 5 mg + Metformin | 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=70, 60, 72, 40) | -0.22 10^6 c/µL | Standard Error 0.04 |
| Saxagliptin 5 mg + Metformin | 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=151, 142, 146, 127) | -0.04 10^6 c/µL | Standard Error 0.023 |
| Saxagliptin 5 mg + Metformin | 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=99, 94, 98, 58) | -0.04 10^6 c/µL | Standard Error 0.026 |
| Saxagliptin 5 mg + Metformin | 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=148, 137, 142, 116) | -0.04 10^6 c/µL | Standard Error 0.031 |
| Saxagliptin 5 mg + Metformin | 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=173, 176, 165, 157) | 0.02 10^6 c/µL | Standard Error 0.017 |
| Saxagliptin 5 mg + Metformin | 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=134, 126, 130, 94) | -0.06 10^6 c/µL | Standard Error 0.024 |
| Saxagliptin 5 mg + Metformin | 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=181, 177, 172, 169) | -0.05 10^6 c/µL | Standard Error 0.016 |
| Saxagliptin 5 mg + Metformin | 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=108, 104, 112, 70) | -0.12 10^6 c/µL | Standard Error 0.027 |
| Saxagliptin 5 mg + Metformin | 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=123, 114, 123, 85) | -0.09 10^6 c/µL | Standard Error 0.024 |
| Saxagliptin 5 mg + Metformin | 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=149, 134, 137, 131) | -0.02 10^6 c/µL | Standard Error 0.019 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 4.73 10^6 c/µL | Standard Error 0.029 |
| Saxagliptin 5 mg + Metformin | 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=70, 61, 73, 41) | -0.21 10^6 c/µL | Standard Error 0.038 |
| Saxagliptin 5 mg + Metformin | 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=170, 167, 160, 144) | 0.03 10^6 c/µL | Standard Error 0.018 |
| Saxagliptin 5 mg + Metformin | 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=61, 50, 64, 31) | -0.25 10^6 c/µL | Standard Error 0.044 |
| Saxagliptin 5 mg + Metformin | 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=156, 154, 146, 139) | 0.01 10^6 c/µL | Standard Error 0.018 |
| Saxagliptin 5 mg + Metformin | 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=77, 67, 75, 42) | -0.15 10^6 c/µL | Standard Error 0.032 |
| Saxagliptin 5 mg + Metformin | 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=167, 166, 159, 140) | 0.05 10^6 c/µL | Standard Error 0.017 |
| Saxagliptin 5 mg + Metformin | 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=178, 178, 174, 166) | -0.04 10^6 c/µL | Standard Error 0.016 |
| Saxagliptin 5 mg + Metformin | 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=155, 158, 149, 141) | -0.01 10^6 c/µL | Standard Error 0.018 |
| Saxagliptin 5 mg + Metformin | 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=81, 74, 78, 45) | -0.17 10^6 c/µL | Standard Error 0.029 |
| Saxagliptin 5 mg + Metformin | 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=162, 153, 154, 147) | 0.02 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 5 mg + Metformin | 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=157, 152, 143, 138) | -0.03 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 5 mg + Metformin | 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=85, 79, 85, 48) | -0.10 10^6 c/µL | Standard Error 0.027 |
| Saxagliptin 5 mg + Metformin | 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=164, 160, 159, 137) | -0.02 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 5 mg + Metformin | 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=176, 174, 166, 160) | -0.02 10^6 c/µL | Standard Error 0.016 |
| Saxagliptin 5 mg + Metformin | 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=161, 155, 154, 137) | -0.02 10^6 c/µL | Standard Error 0.021 |
| Saxagliptin 10 mg + Metformin | 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=61, 50, 64, 31) | -0.09 10^6 c/µL | Standard Error 0.032 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 4.70 10^6 c/µL | Standard Error 0.034 |
| Saxagliptin 10 mg + Metformin | 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=181, 177, 172, 169) | -0.05 10^6 c/µL | Standard Error 0.015 |
| Saxagliptin 10 mg + Metformin | 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=178, 178, 174, 166) | -0.01 10^6 c/µL | Standard Error 0.019 |
| Saxagliptin 10 mg + Metformin | 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=176, 174, 166, 160) | 0.00 10^6 c/µL | Standard Error 0.018 |
| Saxagliptin 10 mg + Metformin | 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=173, 176, 165, 157) | 0.03 10^6 c/µL | Standard Error 0.019 |
| Saxagliptin 10 mg + Metformin | 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=149, 134, 137, 131) | 0.00 10^6 c/µL | Standard Error 0.021 |
| Saxagliptin 10 mg + Metformin | 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=170, 167, 160, 144) | 0.09 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 10 mg + Metformin | 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=156, 154, 146, 139) | 0.04 10^6 c/µL | Standard Error 0.024 |
| Saxagliptin 10 mg + Metformin | 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=167, 166, 159, 140) | 0.07 10^6 c/µL | Standard Error 0.021 |
| Saxagliptin 10 mg + Metformin | 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=155, 158, 149, 141) | 0.04 10^6 c/µL | Standard Error 0.018 |
| Saxagliptin 10 mg + Metformin | 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=162, 153, 154, 147) | 0.06 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 10 mg + Metformin | 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=157, 152, 143, 138) | 0.01 10^6 c/µL | Standard Error 0.02 |
| Saxagliptin 10 mg + Metformin | 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=164, 160, 159, 137) | 0.01 10^6 c/µL | Standard Error 0.019 |
| Saxagliptin 10 mg + Metformin | 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=161, 155, 154, 137) | 0.02 10^6 c/µL | Standard Error 0.022 |
| Saxagliptin 10 mg + Metformin | 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=152, 149, 146, 122) | 0.02 10^6 c/µL | Standard Error 0.021 |
| Saxagliptin 10 mg + Metformin | 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=151, 142, 146, 127) | 0.00 10^6 c/µL | Standard Error 0.021 |
| Saxagliptin 10 mg + Metformin | 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=148, 137, 142, 116) | -0.01 10^6 c/µL | Standard Error 0.023 |
| Saxagliptin 10 mg + Metformin | 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=134, 126, 130, 94) | -0.02 10^6 c/µL | Standard Error 0.023 |
| Saxagliptin 10 mg + Metformin | 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=123, 114, 123, 85) | -0.07 10^6 c/µL | Standard Error 0.03 |
| Saxagliptin 10 mg + Metformin | 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=108, 104, 112, 70) | -0.07 10^6 c/µL | Standard Error 0.027 |
| Saxagliptin 10 mg + Metformin | 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=99, 94, 98, 58) | -0.06 10^6 c/µL | Standard Error 0.027 |
| Saxagliptin 10 mg + Metformin | 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=92, 88, 90, 52) | -0.06 10^6 c/µL | Standard Error 0.027 |
| Saxagliptin 10 mg + Metformin | 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=85, 79, 85, 48) | -0.06 10^6 c/µL | Standard Error 0.031 |
| Saxagliptin 10 mg + Metformin | 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=81, 74, 78, 45) | -0.11 10^6 c/µL | Standard Error 0.029 |
| Saxagliptin 10 mg + Metformin | 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=77, 67, 75, 42) | -0.12 10^6 c/µL | Standard Error 0.034 |
| Saxagliptin 10 mg + Metformin | 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=70, 61, 73, 41) | -0.09 10^6 c/µL | Standard Error 0.033 |
| Saxagliptin 10 mg + Metformin | 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=70, 60, 72, 40) | -0.12 10^6 c/µL | Standard Error 0.032 |
| Placebo+ Metformin | 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=152, 149, 146, 122) | 0.00 10^6 c/µL | Standard Error 0.022 |
| Placebo+ Metformin | 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=161, 155, 154, 137) | -0.01 10^6 c/µL | Standard Error 0.021 |
| Placebo+ Metformin | 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=176, 174, 166, 160) | 0.03 10^6 c/µL | Standard Error 0.017 |
| Placebo+ Metformin | 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=92, 88, 90, 52) | -0.08 10^6 c/µL | Standard Error 0.031 |
| Placebo+ Metformin | 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=164, 160, 159, 137) | -0.03 10^6 c/µL | Standard Error 0.024 |
| Placebo+ Metformin | 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=157, 152, 143, 138) | -0.02 10^6 c/µL | Standard Error 0.023 |
| Placebo+ Metformin | Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 4.66 10^6 c/µL | Standard Error 0.033 |
| Placebo+ Metformin | 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=85, 79, 85, 48) | -0.13 10^6 c/µL | Standard Error 0.041 |
| Placebo+ Metformin | 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=162, 153, 154, 147) | 0.03 10^6 c/µL | Standard Error 0.021 |
| Placebo+ Metformin | 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=155, 158, 149, 141) | 0.03 10^6 c/µL | Standard Error 0.021 |
| Placebo+ Metformin | 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=70, 60, 72, 40) | -0.13 10^6 c/µL | Standard Error 0.044 |
| Placebo+ Metformin | 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=81, 74, 78, 45) | -0.20 10^6 c/µL | Standard Error 0.035 |
| Placebo+ Metformin | 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=167, 166, 159, 140) | 0.08 10^6 c/µL | Standard Error 0.02 |
| Placebo+ Metformin | 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=156, 154, 146, 139) | 0.04 10^6 c/µL | Standard Error 0.022 |
| Placebo+ Metformin | 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=178, 178, 174, 166) | 0.01 10^6 c/µL | Standard Error 0.018 |
| Placebo+ Metformin | 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=77, 67, 75, 42) | -0.16 10^6 c/µL | Standard Error 0.041 |
| Placebo+ Metformin | 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=61, 50, 64, 31) | -0.15 10^6 c/µL | Standard Error 0.048 |
| Placebo+ Metformin | 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=170, 167, 160, 144) | 0.04 10^6 c/µL | Standard Error 0.022 |
| Placebo+ Metformin | 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=149, 134, 137, 131) | 0.00 10^6 c/µL | Standard Error 0.022 |
| Placebo+ Metformin | 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=181, 177, 172, 169) | -0.03 10^6 c/µL | Standard Error 0.015 |
| Placebo+ Metformin | 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=123, 114, 123, 85) | -0.07 10^6 c/µL | Standard Error 0.028 |
| Placebo+ Metformin | 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=134, 126, 130, 94) | -0.09 10^6 c/µL | Standard Error 0.029 |
| Placebo+ Metformin | 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=70, 61, 73, 41) | -0.16 10^6 c/µL | Standard Error 0.037 |
| Placebo+ Metformin | 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=108, 104, 112, 70) | -0.14 10^6 c/µL | Standard Error 0.031 |
| Placebo+ Metformin | 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=148, 137, 142, 116) | -0.02 10^6 c/µL | Standard Error 0.024 |
| Placebo+ Metformin | 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=151, 142, 146, 127) | -0.03 10^6 c/µL | Standard Error 0.024 |
| Placebo+ Metformin | 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=173, 176, 165, 157) | 0.03 10^6 c/µL | Standard Error 0.019 |
| Placebo+ Metformin | 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=99, 94, 98, 58) | -0.11 10^6 c/µL | Standard Error 0.034 |
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 + Metformin | Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 7.23 10^3 c/µL | Standard Error 0.136 |
| Saxagliptin 2.5 mg + Metformin | 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=69, 60, 72, 40) | -0.45 10^3 c/µL | Standard Error 0.16 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 142, 145, 125) | -0.14 10^3 c/µL | Standard Error 0.116 |
| Saxagliptin 2.5 mg + Metformin | 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=172, 174, 163, 153) | 0.15 10^3 c/µL | Standard Error 0.104 |
| Saxagliptin 2.5 mg + Metformin | 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=98, 92, 95, 57) | -0.10 10^3 c/µL | Standard Error 0.142 |
| Saxagliptin 2.5 mg + Metformin | 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=147, 136, 140, 115) | -0.10 10^3 c/µL | Standard Error 0.117 |
| Saxagliptin 2.5 mg + Metformin | 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=134, 126, 130, 94) | -0.19 10^3 c/µL | Standard Error 0.122 |
| Saxagliptin 2.5 mg + Metformin | 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=150, 149, 146, 121) | 0.34 10^3 c/µL | Standard Error 0.13 |
| Saxagliptin 2.5 mg + Metformin | 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=105, 104, 111, 68) | -0.36 10^3 c/µL | Standard Error 0.14 |
| Saxagliptin 2.5 mg + Metformin | 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=122, 114, 123, 85) | -0.29 10^3 c/µL | Standard Error 0.141 |
| Saxagliptin 2.5 mg + Metformin | 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=148, 130, 137, 128) | 0.42 10^3 c/µL | Standard Error 0.108 |
| Saxagliptin 2.5 mg + Metformin | 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=70, 60, 72, 41) | -0.40 10^3 c/µL | Standard Error 0.185 |
| Saxagliptin 2.5 mg + Metformin | 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=169, 166, 159, 142) | 0.18 10^3 c/µL | Standard Error 0.1 |
| Saxagliptin 2.5 mg + Metformin | 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=61, 49, 63, 31) | -0.58 10^3 c/µL | Standard Error 0.175 |
| Saxagliptin 2.5 mg + Metformin | 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=156, 152, 145, 136) | 0.57 10^3 c/µL | Standard Error 0.142 |
| Saxagliptin 2.5 mg + Metformin | 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=176, 176, 171, 166) | 0.19 10^3 c/µL | Standard Error 0.111 |
| Saxagliptin 2.5 mg + Metformin | 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=76, 67, 75, 42) | -0.15 10^3 c/µL | Standard Error 0.179 |
| Saxagliptin 2.5 mg + Metformin | 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=166, 166, 159, 137) | 0.28 10^3 c/µL | Standard Error 0.103 |
| Saxagliptin 2.5 mg + Metformin | 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=155, 158, 149, 139) | 0.67 10^3 c/µL | Standard Error 0.121 |
| Saxagliptin 2.5 mg + Metformin | 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=77, 72, 78, 45) | -0.19 10^3 c/µL | Standard Error 0.17 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 153, 154, 146) | 0.23 10^3 c/µL | Standard Error 0.112 |
| Saxagliptin 2.5 mg + Metformin | 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=157, 152, 143, 138) | 0.45 10^3 c/µL | Standard Error 0.112 |
| Saxagliptin 2.5 mg + Metformin | 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=175, 172, 165, 158) | 0.11 10^3 c/µL | Standard Error 0.089 |
| Saxagliptin 2.5 mg + Metformin | 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=85, 78, 85, 47) | -0.01 10^3 c/µL | Standard Error 0.156 |
| Saxagliptin 2.5 mg + Metformin | 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=162, 160, 157, 135) | 0.13 10^3 c/µL | Standard Error 0.103 |
| Saxagliptin 2.5 mg + Metformin | 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=160, 155, 154, 136) | 0.27 10^3 c/µL | Standard Error 0.091 |
| Saxagliptin 2.5 mg + Metformin | 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=178, 175, 171, 169) | 0.10 10^3 c/µL | Standard Error 0.093 |
| Saxagliptin 2.5 mg + Metformin | 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=90, 87, 88, 50) | -0.16 10^3 c/µL | Standard Error 0.162 |
| Saxagliptin 5 mg + Metformin | 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=69, 60, 72, 40) | -0.34 10^3 c/µL | Standard Error 0.228 |
| Saxagliptin 5 mg + Metformin | 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=150, 149, 146, 121) | 0.10 10^3 c/µL | Standard Error 0.137 |
| Saxagliptin 5 mg + Metformin | 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=156, 152, 145, 136) | 0.30 10^3 c/µL | Standard Error 0.148 |
| Saxagliptin 5 mg + Metformin | 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=98, 92, 95, 57) | -0.26 10^3 c/µL | Standard Error 0.161 |
| Saxagliptin 5 mg + Metformin | 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=85, 78, 85, 47) | -0.42 10^3 c/µL | Standard Error 0.161 |
| Saxagliptin 5 mg + Metformin | 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=150, 142, 145, 125) | -0.14 10^3 c/µL | Standard Error 0.16 |
| Saxagliptin 5 mg + Metformin | 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=162, 160, 157, 135) | 0.12 10^3 c/µL | Standard Error 0.161 |
| Saxagliptin 5 mg + Metformin | 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=157, 152, 143, 138) | 0.36 10^3 c/µL | Standard Error 0.138 |
| Saxagliptin 5 mg + Metformin | 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=166, 166, 159, 137) | 0.07 10^3 c/µL | Standard Error 0.127 |
| Saxagliptin 5 mg + Metformin | 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=147, 136, 140, 115) | -0.10 10^3 c/µL | Standard Error 0.123 |
| Saxagliptin 5 mg + Metformin | 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=172, 174, 163, 153) | -0.03 10^3 c/µL | Standard Error 0.116 |
| Saxagliptin 5 mg + Metformin | 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=105, 104, 111, 68) | -0.11 10^3 c/µL | Standard Error 0.15 |
| Saxagliptin 5 mg + Metformin | 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=176, 176, 171, 166) | 0.04 10^3 c/µL | Standard Error 0.131 |
| Saxagliptin 5 mg + Metformin | 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=134, 126, 130, 94) | -0.18 10^3 c/µL | Standard Error 0.157 |
| Saxagliptin 5 mg + Metformin | 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=77, 72, 78, 45) | -0.38 10^3 c/µL | Standard Error 0.226 |
| Saxagliptin 5 mg + Metformin | 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=175, 172, 165, 158) | 0.02 10^3 c/µL | Standard Error 0.102 |
| Saxagliptin 5 mg + Metformin | 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=155, 158, 149, 139) | 0.23 10^3 c/µL | Standard Error 0.135 |
| Saxagliptin 5 mg + Metformin | 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=122, 114, 123, 85) | -0.34 10^3 c/µL | Standard Error 0.136 |
| Saxagliptin 5 mg + Metformin | 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=178, 175, 171, 169) | -0.03 10^3 c/µL | Standard Error 0.116 |
| Saxagliptin 5 mg + Metformin | 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=70, 60, 72, 41) | -0.72 10^3 c/µL | Standard Error 0.212 |
| Saxagliptin 5 mg + Metformin | 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=61, 49, 63, 31) | -0.80 10^3 c/µL | Standard Error 0.27 |
| Saxagliptin 5 mg + Metformin | 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=148, 130, 137, 128) | 0.37 10^3 c/µL | Standard Error 0.126 |
| Saxagliptin 5 mg + Metformin | Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 7.25 10^3 c/µL | Standard Error 0.167 |
| Saxagliptin 5 mg + Metformin | 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=90, 87, 88, 50) | -0.27 10^3 c/µL | Standard Error 0.148 |
| Saxagliptin 5 mg + Metformin | 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=160, 155, 154, 136) | 0.05 10^3 c/µL | Standard Error 0.131 |
| Saxagliptin 5 mg + Metformin | 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=169, 166, 159, 142) | 0.08 10^3 c/µL | Standard Error 0.134 |
| Saxagliptin 5 mg + Metformin | 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=162, 153, 154, 146) | -0.02 10^3 c/µL | Standard Error 0.13 |
| Saxagliptin 5 mg + Metformin | 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=76, 67, 75, 42) | -0.18 10^3 c/µL | Standard Error 0.178 |
| Saxagliptin 10 mg + Metformin | 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=134, 126, 130, 94) | -0.25 10^3 c/µL | Standard Error 0.105 |
| Saxagliptin 10 mg + Metformin | Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 7.12 10^3 c/µL | Standard Error 0.136 |
| Saxagliptin 10 mg + Metformin | 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=178, 175, 171, 169) | 0.17 10^3 c/µL | Standard Error 0.102 |
| Saxagliptin 10 mg + Metformin | 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=176, 176, 171, 166) | -0.02 10^3 c/µL | Standard Error 0.1 |
| Saxagliptin 10 mg + Metformin | 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=175, 172, 165, 158) | 0.07 10^3 c/µL | Standard Error 0.092 |
| Saxagliptin 10 mg + Metformin | 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=172, 174, 163, 153) | 0.19 10^3 c/µL | Standard Error 0.106 |
| Saxagliptin 10 mg + Metformin | 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=148, 130, 137, 128) | 0.23 10^3 c/µL | Standard Error 0.105 |
| Saxagliptin 10 mg + Metformin | 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=169, 166, 159, 142) | 0.26 10^3 c/µL | Standard Error 0.114 |
| Saxagliptin 10 mg + Metformin | 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=156, 152, 145, 136) | 0.24 10^3 c/µL | Standard Error 0.121 |
| Saxagliptin 10 mg + Metformin | 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=166, 166, 159, 137) | 0.16 10^3 c/µL | Standard Error 0.115 |
| Saxagliptin 10 mg + Metformin | 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=155, 158, 149, 139) | 0.39 10^3 c/µL | Standard Error 0.114 |
| Saxagliptin 10 mg + Metformin | 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=162, 153, 154, 146) | 0.19 10^3 c/µL | Standard Error 0.111 |
| Saxagliptin 10 mg + Metformin | 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=157, 152, 143, 138) | 0.24 10^3 c/µL | Standard Error 0.112 |
| Saxagliptin 10 mg + Metformin | 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=162, 160, 157, 135) | 0.11 10^3 c/µL | Standard Error 0.097 |
| Saxagliptin 10 mg + Metformin | 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=160, 155, 154, 136) | 0.21 10^3 c/µL | Standard Error 0.109 |
| Saxagliptin 10 mg + Metformin | 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=150, 149, 146, 121) | 0.02 10^3 c/µL | Standard Error 0.105 |
| Saxagliptin 10 mg + Metformin | 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=150, 142, 145, 125) | -0.20 10^3 c/µL | Standard Error 0.114 |
| Saxagliptin 10 mg + Metformin | 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=147, 136, 140, 115) | -0.02 10^3 c/µL | Standard Error 0.168 |
| Saxagliptin 10 mg + Metformin | 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=122, 114, 123, 85) | -0.21 10^3 c/µL | Standard Error 0.153 |
| Saxagliptin 10 mg + Metformin | 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=105, 104, 111, 68) | -0.31 10^3 c/µL | Standard Error 0.102 |
| Saxagliptin 10 mg + Metformin | 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=98, 92, 95, 57) | -0.05 10^3 c/µL | Standard Error 0.183 |
| Saxagliptin 10 mg + Metformin | 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=90, 87, 88, 50) | -0.12 10^3 c/µL | Standard Error 0.155 |
| Saxagliptin 10 mg + Metformin | 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=85, 78, 85, 47) | 0.13 10^3 c/µL | Standard Error 0.174 |
| Saxagliptin 10 mg + Metformin | 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=77, 72, 78, 45) | -0.55 10^3 c/µL | Standard Error 0.144 |
| Saxagliptin 10 mg + Metformin | 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=76, 67, 75, 42) | -0.18 10^3 c/µL | Standard Error 0.152 |
| Saxagliptin 10 mg + Metformin | 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=70, 60, 72, 41) | -0.38 10^3 c/µL | Standard Error 0.142 |
| Saxagliptin 10 mg + Metformin | 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=69, 60, 72, 40) | -0.13 10^3 c/µL | Standard Error 0.143 |
| Saxagliptin 10 mg + Metformin | 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=61, 49, 63, 31) | -0.36 10^3 c/µL | Standard Error 0.17 |
| Placebo+ Metformin | 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=160, 155, 154, 136) | 0.14 10^3 c/µL | Standard Error 0.141 |
| Placebo+ Metformin | 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=162, 160, 157, 135) | 0.10 10^3 c/µL | Standard Error 0.135 |
| Placebo+ Metformin | 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=176, 176, 171, 166) | 0.22 10^3 c/µL | Standard Error 0.117 |
| Placebo+ Metformin | 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=90, 87, 88, 50) | -0.32 10^3 c/µL | Standard Error 0.225 |
| Placebo+ Metformin | 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=157, 152, 143, 138) | 0.50 10^3 c/µL | Standard Error 0.12 |
| Placebo+ Metformin | 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=162, 153, 154, 146) | 0.39 10^3 c/µL | Standard Error 0.142 |
| Placebo+ Metformin | 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=61, 49, 63, 31) | -0.71 10^3 c/µL | Standard Error 0.201 |
| Placebo+ Metformin | 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=85, 78, 85, 47) | -0.07 10^3 c/µL | Standard Error 0.235 |
| Placebo+ Metformin | 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=155, 158, 149, 139) | 0.58 10^3 c/µL | Standard Error 0.135 |
| Placebo+ Metformin | 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=166, 166, 159, 137) | 0.42 10^3 c/µL | Standard Error 0.139 |
| Placebo+ Metformin | 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=69, 60, 72, 40) | -0.35 10^3 c/µL | Standard Error 0.203 |
| Placebo+ Metformin | 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=77, 72, 78, 45) | -0.54 10^3 c/µL | Standard Error 0.18 |
| Placebo+ Metformin | 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=156, 152, 145, 136) | 0.33 10^3 c/µL | Standard Error 0.132 |
| Placebo+ Metformin | 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=169, 166, 159, 142) | 0.37 10^3 c/µL | Standard Error 0.13 |
| Placebo+ Metformin | 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=178, 175, 171, 169) | 0.11 10^3 c/µL | Standard Error 0.113 |
| Placebo+ Metformin | 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=76, 67, 75, 42) | -0.38 10^3 c/µL | Standard Error 0.177 |
| Placebo+ Metformin | 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=148, 130, 137, 128) | 0.39 10^3 c/µL | Standard Error 0.115 |
| Placebo+ Metformin | 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=172, 174, 163, 153) | 0.03 10^3 c/µL | Standard Error 0.109 |
| Placebo+ Metformin | Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period | Baseline (Week 0) (n=192, 191, 181, 179) | 7.19 10^3 c/µL | Standard Error 0.136 |
| Placebo+ Metformin | 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=122, 114, 123, 85) | -0.38 10^3 c/µL | Standard Error 0.197 |
| Placebo+ Metformin | 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=134, 126, 130, 94) | -0.30 10^3 c/µL | Standard Error 0.172 |
| Placebo+ Metformin | 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=147, 136, 140, 115) | -0.39 10^3 c/µL | Standard Error 0.148 |
| Placebo+ Metformin | 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=70, 60, 72, 41) | -0.37 10^3 c/µL | Standard Error 0.19 |
| Placebo+ Metformin | 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=105, 104, 111, 68) | -0.54 10^3 c/µL | Standard Error 0.178 |
| Placebo+ Metformin | 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=150, 142, 145, 125) | -0.36 10^3 c/µL | Standard Error 0.12 |
| Placebo+ Metformin | 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=150, 149, 146, 121) | 0.10 10^3 c/µL | Standard Error 0.135 |
| Placebo+ Metformin | 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=175, 172, 165, 158) | 0.07 10^3 c/µL | Standard Error 0.115 |
| Placebo+ Metformin | 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=98, 92, 95, 57) | -0.15 10^3 c/µL | Standard Error 0.202 |
Other Pre-specified
Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period
Time frame: 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 + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -1.0 mmHg | Standard Error 0.6 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -0.7 mmHg | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 89 (n=124, 117, 125, 86) | -1.2 mmHg | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -0.1 mmHg | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 50 (n=155, 147, 151, 130) | -1.1 mmHg | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -1.4 mmHg | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 10 (n=116, 108, 101, 101) | 0.3 mmHg | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | 0.4 mmHg | Standard Error 1.2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | 2.1 mmHg | Standard Error 1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -1.2 mmHg | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -2.2 mmHg | Standard Error 0.9 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -0.2 mmHg | Standard Error 0.9 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -0.6 mmHg | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -0.7 mmHg | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -0.6 mmHg | Standard Error 1.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.8 mmHg | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -0.7 mmHg | Standard Error 1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -1.3 mmHg | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | -0.3 mmHg | Standard Error 0.9 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -1.1 mmHg | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -0.2 mmHg | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 155, 138) | -0.9 mmHg | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -0.1 mmHg | Standard Error 1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -2.8 mmHg | Standard Error 1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | 0.7 mmHg | Standard Error 1.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -0.9 mmHg | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -0.3 mmHg | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -1.1 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | 0.0 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 50 (n=155, 147, 151, 130) | -1.7 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.3 mmHg | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | 0.7 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -1.2 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 10 (n=116, 108, 101, 101) | -0.5 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 89 (n=124, 117, 125, 86) | -0.8 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -0.9 mmHg | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -0.4 mmHg | Standard Error 1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | -1.4 mmHg | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -1.0 mmHg | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -1.1 mmHg | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -0.4 mmHg | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -1.0 mmHg | Standard Error 0.6 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | -1.4 mmHg | Standard Error 1.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -0.7 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -1.6 mmHg | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -1.0 mmHg | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -0.6 mmHg | Standard Error 1.4 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -1.8 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -1.2 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -2.6 mmHg | Standard Error 1.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -1.3 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | 0.3 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 155, 138) | -0.5 mmHg | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -1.9 mmHg | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | -1.6 mmHg | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -0.9 mmHg | Standard Error 0.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -1.3 mmHg | Standard Error 0.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -0.5 mmHg | Standard Error 0.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -1.5 mmHg | Standard Error 0.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 10 (n=116, 108, 101, 101) | -1.6 mmHg | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -2.1 mmHg | Standard Error 0.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -2.2 mmHg | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -1.7 mmHg | Standard Error 0.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -2.3 mmHg | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -2.1 mmHg | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -1.6 mmHg | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -2.5 mmHg | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 155, 138) | -1.6 mmHg | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -1.9 mmHg | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 50 (n=155, 147, 151, 130) | -1.5 mmHg | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.9 mmHg | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -1.6 mmHg | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 89 (n=124, 117, 125, 86) | -1.9 mmHg | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -2.3 mmHg | Standard Error 0.9 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -1.1 mmHg | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -1.2 mmHg | Standard Error 1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | -3.0 mmHg | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -2.7 mmHg | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | -0.9 mmHg | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -1.7 mmHg | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -2.3 mmHg | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -1.6 mmHg | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -2.8 mmHg | Standard Error 1.6 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -3.1 mmHg | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 155, 138) | -1.6 mmHg | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -2.4 mmHg | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -2.6 mmHg | Standard Error 1.6 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | -2.7 mmHg | Standard Error 1.5 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -1.6 mmHg | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -1.9 mmHg | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -1.4 mmHg | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -4.6 mmHg | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -1.8 mmHg | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -1.0 mmHg | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -2.1 mmHg | Standard Error 0.9 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | -2.0 mmHg | Standard Error 1.7 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -1.7 mmHg | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 10 (n=116, 108, 101, 101) | -3.4 mmHg | Standard Error 0.9 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -1.5 mmHg | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | -1.6 mmHg | Standard Error 1.7 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 89 (n=124, 117, 125, 86) | -2.1 mmHg | Standard Error 1 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -2.2 mmHg | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -3.6 mmHg | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -1.8 mmHg | Standard Error 1 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.7 mmHg | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -1.4 mmHg | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -3.6 mmHg | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | Change from BL at Week 50 (n=155, 147, 151, 130) | -1.4 mmHg | Standard Error 0.8 |
Other Pre-specified
Changes From Baseline in Heart Rate During the ST + LT Period
Time frame: 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 + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -0.3 beats/min | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -0.6 beats/min | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 89 (n=124, 116, 125, 86) | -1.5 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -0.2 beats/min | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 10 (n=116, 106, 100, 101) | -0.5 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -0.0 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -0.2 beats/min | Standard Error 0.9 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.8 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | 0.3 beats/min | Standard Error 1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -0.0 beats/min | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -0.6 beats/min | Standard Error 0.9 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 50 (n=154, 147, 151, 130) | -1.0 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -0.2 beats/min | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | 0.4 beats/min | Standard Error 0.9 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.3 beats/min | Standard Error 1.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -1.3 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | 0.5 beats/min | Standard Error 0.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -0.6 beats/min | Standard Error 0.9 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -0.6 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | -0.8 beats/min | Standard Error 1.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -0.1 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -0.5 beats/min | Standard Error 0.9 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 154, 138) | -0.7 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | 0.1 beats/min | Standard Error 1.2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -0.1 beats/min | Standard Error 0.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | -1.7 beats/min | Standard Error 1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -1.2 beats/min | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | 0.8 beats/min | Standard Error 0.6 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | 0.6 beats/min | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 50 (n=154, 147, 151, 130) | 0.8 beats/min | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -0.3 beats/min | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | 0.4 beats/min | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -0.0 beats/min | Standard Error 0.9 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 10 (n=116, 106, 100, 101) | 0.9 beats/min | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 89 (n=124, 116, 125, 86) | -0.3 beats/min | Standard Error 0.9 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | 1.3 beats/min | Standard Error 0.6 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | 0.5 beats/min | Standard Error 0.9 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | -2.8 beats/min | Standard Error 1.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | 0.7 beats/min | Standard Error 0.6 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | 1.0 beats/min | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | 1.4 beats/min | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | 0.4 beats/min | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | -0.0 beats/min | Standard Error 1.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | 1.6 beats/min | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | 1.0 beats/min | Standard Error 0.6 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | 0.9 beats/min | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -0.9 beats/min | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -0.9 beats/min | Standard Error 1.4 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | 2.4 beats/min | Standard Error 0.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -2.2 beats/min | Standard Error 1.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | 0.2 beats/min | Standard Error 0.7 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -0.7 beats/min | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | -1.7 beats/min | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 154, 138) | 0.5 beats/min | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | -1.2 beats/min | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -0.4 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -0.0 beats/min | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -0.2 beats/min | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | 0.6 beats/min | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 10 (n=116, 106, 100, 101) | 0.2 beats/min | Standard Error 1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | 0.1 beats/min | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | 1.0 beats/min | Standard Error 0.9 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -0.5 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | 0.3 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -0.3 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | 0.3 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.8 beats/min | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | 0.4 beats/min | Standard Error 0.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 154, 138) | -0.3 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -0.3 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 50 (n=154, 147, 151, 130) | 0.1 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -0.5 beats/min | Standard Error 0.9 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 89 (n=124, 116, 125, 86) | -0.2 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | 0.6 beats/min | Standard Error 0.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -0.8 beats/min | Standard Error 1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -0.9 beats/min | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | -0.6 beats/min | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -0.0 beats/min | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | 0.2 beats/min | Standard Error 1.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -1.1 beats/min | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -1.2 beats/min | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.5 beats/min | Standard Error 0.9 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -1.1 beats/min | Standard Error 1.6 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -0.9 beats/min | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 154, 138) | -0.1 beats/min | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -0.7 beats/min | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -1.8 beats/min | Standard Error 1.5 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | -1.2 beats/min | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -1.6 beats/min | Standard Error 0.9 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -0.8 beats/min | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | 0.1 beats/min | Standard Error 0.6 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -2.8 beats/min | Standard Error 1.4 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -0.5 beats/min | Standard Error 0.9 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -0.5 beats/min | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -1.5 beats/min | Standard Error 0.9 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | -0.9 beats/min | Standard Error 1.4 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -1.5 beats/min | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 10 (n=116, 106, 100, 101) | -1.5 beats/min | Standard Error 0.9 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | 0.7 beats/min | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | -2.7 beats/min | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 89 (n=124, 116, 125, 86) | -1.6 beats/min | Standard Error 1 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -0.6 beats/min | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -1.8 beats/min | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -1.4 beats/min | Standard Error 0.9 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 50 (n=154, 147, 151, 130) | -1.0 beats/min | Standard Error 0.8 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -0.5 beats/min | Standard Error 0.7 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -2.4 beats/min | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Heart Rate During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -0.6 beats/min | Standard Error 0.8 |
Other Pre-specified
Changes From Baseline in Systolic Blood Pressure During the ST + LT Period
Time frame: 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 + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -1.6 mmHg | Standard Error 1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -2.7 mmHg | Standard Error 1.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 89 (n=124, 117, 125, 86) | -3.7 mmHg | Standard Error 1.3 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -2.8 mmHg | Standard Error 1.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 50 (n=155, 147, 151, 130) | -2.6 mmHg | Standard Error 1.3 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -1.9 mmHg | Standard Error 1.2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 10 (n=116, 108, 101, 101) | -2.1 mmHg | Standard Error 1.4 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -0.1 mmHg | Standard Error 2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | 0.8 mmHg | Standard Error 1.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -2.9 mmHg | Standard Error 1.2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -3.2 mmHg | Standard Error 1.5 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -0.1 mmHg | Standard Error 1.5 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -2.2 mmHg | Standard Error 1.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -2.0 mmHg | Standard Error 1.2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -0.4 mmHg | Standard Error 1.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.6 mmHg | Standard Error 1.3 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | 0.3 mmHg | Standard Error 1.7 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -4.3 mmHg | Standard Error 1.2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | -0.0 mmHg | Standard Error 2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -2.9 mmHg | Standard Error 1.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -0.7 mmHg | Standard Error 1.3 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 155, 138) | -3.6 mmHg | Standard Error 1.2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -0.4 mmHg | Standard Error 1.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -2.6 mmHg | Standard Error 2.1 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | -0.7 mmHg | Standard Error 1.8 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -2.6 mmHg | Standard Error 1.2 |
| Saxagliptin 2.5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -2.0 mmHg | Standard Error 1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -1.8 mmHg | Standard Error 1.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | 2.9 mmHg | Standard Error 2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 50 (n=155, 147, 151, 130) | -1.7 mmHg | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | 0.9 mmHg | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | 2.0 mmHg | Standard Error 1.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -0.6 mmHg | Standard Error 1.4 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 10 (n=116, 108, 101, 101) | -3.3 mmHg | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 89 (n=124, 117, 125, 86) | 0.3 mmHg | Standard Error 1.4 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -2.3 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | 0.6 mmHg | Standard Error 1.5 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | 3.1 mmHg | Standard Error 2.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -2.8 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -2.5 mmHg | Standard Error 1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -2.3 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -3.5 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | -0.4 mmHg | Standard Error 2.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -2.2 mmHg | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -4.1 mmHg | Standard Error 1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -2.2 mmHg | Standard Error 1.1 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | 2.2 mmHg | Standard Error 2.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -0.0 mmHg | Standard Error 1.8 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -3.1 mmHg | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | 0.9 mmHg | Standard Error 2.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -3.6 mmHg | Standard Error 1.2 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | 2.0 mmHg | Standard Error 1.6 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 155, 138) | -1.1 mmHg | Standard Error 1.3 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -4.2 mmHg | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | 0.7 mmHg | Standard Error 1.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -1.6 mmHg | Standard Error 0.9 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -3.3 mmHg | Standard Error 0.9 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -2.8 mmHg | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -4.2 mmHg | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 10 (n=116, 108, 101, 101) | -2.8 mmHg | Standard Error 1.4 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -4.3 mmHg | Standard Error 1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -3.4 mmHg | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -4.4 mmHg | Standard Error 1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -4.2 mmHg | Standard Error 1.1 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -4.9 mmHg | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -3.1 mmHg | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -3.8 mmHg | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 155, 138) | -2.5 mmHg | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -3.3 mmHg | Standard Error 1.3 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 50 (n=155, 147, 151, 130) | -1.9 mmHg | Standard Error 1.2 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.6 mmHg | Standard Error 1.3 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -0.7 mmHg | Standard Error 1.3 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 89 (n=124, 117, 125, 86) | -1.7 mmHg | Standard Error 1.4 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -2.8 mmHg | Standard Error 1.4 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -1.3 mmHg | Standard Error 1.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | 1.5 mmHg | Standard Error 1.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | -1.5 mmHg | Standard Error 1.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | 1.5 mmHg | Standard Error 1.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | 3.5 mmHg | Standard Error 1.7 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | 0.2 mmHg | Standard Error 1.8 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | 1.7 mmHg | Standard Error 1.9 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 37 (n=154, 151, 149, 123) | -2.3 mmHg | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 206 (n=61, 53, 64, 33) | -0.4 mmHg | Standard Error 2.2 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 128 (n=94, 88, 90, 52) | -2.5 mmHg | Standard Error 2 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 30 (n=162, 156, 155, 138) | -3.4 mmHg | Standard Error 1.4 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 24 (n=165, 160, 161, 140) | -4.5 mmHg | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 193 (n=70, 60, 72, 40) | -1.4 mmHg | Standard Error 2.4 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 141 (n=87, 82, 85, 49) | 0.3 mmHg | Standard Error 2.3 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 22 (n=146, 140, 136, 126) | -4.7 mmHg | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 20 (n=163, 155, 153, 147) | -4.3 mmHg | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 4 (n=178, 179, 175, 164) | -2.9 mmHg | Standard Error 1.1 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 154 (n=84, 75, 79, 45) | -2.8 mmHg | Standard Error 2.3 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 18 (n=144, 141, 132, 123) | -4.1 mmHg | Standard Error 1.4 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 16 (n=166, 164, 156, 140) | -2.6 mmHg | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 14 (n=132, 129, 124, 116) | -2.6 mmHg | Standard Error 1.4 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 167 (n=78, 67, 75, 42) | -1.8 mmHg | Standard Error 2.5 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 12 (n=170, 166, 161, 138) | -4.3 mmHg | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 10 (n=116, 108, 101, 101) | -6.8 mmHg | Standard Error 1.5 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 2 (n=182, 181, 176, 170) | -3.3 mmHg | Standard Error 1.1 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 180 (n=71, 63, 74, 41) | 2.7 mmHg | Standard Error 2.5 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 89 (n=124, 117, 125, 86) | 0.3 mmHg | Standard Error 1.6 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 8 (n=175, 176, 170, 152) | -3.7 mmHg | Standard Error 1.2 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 102 (n=111, 107, 113, 73) | -2.0 mmHg | Standard Error 2 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 76 (n=134, 126, 133, 98) | -1.7 mmHg | Standard Error 1.6 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 63 (n=151, 138, 145, 117) | -0.0 mmHg | Standard Error 1.3 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 6 (n=178, 176, 171, 162) | -2.8 mmHg | Standard Error 1.1 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 115 (n=100, 94, 98, 58) | -2.8 mmHg | Standard Error 1.9 |
| Placebo+ Metformin | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | Change from BL at Week 50 (n=155, 147, 151, 130) | -2.9 mmHg | Standard Error 1.5 |
Other Pre-specified
Confirmed Hypoglycemia During the ST + LT Treatment Period
'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose \<= 50 mg/dL and associated symptoms.
Time frame: AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla
Population: Treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 2.5 mg + Metformin | Confirmed Hypoglycemia During the ST + LT Treatment Period | 3 participants |
| Saxagliptin 5 mg + Metformin | Confirmed Hypoglycemia During the ST + LT Treatment Period | 2 participants |
| Saxagliptin 10 mg + Metformin | Confirmed Hypoglycemia During the ST + LT Treatment Period | 3 participants |
| Placebo+ Metformin | Confirmed Hypoglycemia During the ST + LT Treatment Period | 1 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: Number of Participants Analyzed=Treated Participants; BL n=normal or abnormal ECG status at baseline of the cohort of participants with measure at given time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 24 (BL n=58, 58, 56, 41) | 16 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 12 (BL n=108,109,104,104) | 11 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 12 (BL n=69, 66, 70, 58) | 14 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 12(BL n=69, 66, 70, 58) | 55 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 24 (BL n=96, 87, 83, 77) | 82 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 24 (BL n=96, 87, 83, 77) | 14 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 12(BL n=108, 109, 104, 104) | 97 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 24(BL n=58, 58, 56, 41) | 42 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 76 (BL n=94, 89, 92, 81) | 75 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 76 (BL n=94, 89, 92, 81) | 19 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 76 (BL n=51, 52, 59, 44) | 13 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 76 (BL n=51,52,59,44) | 38 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 102 (BL n=80, 66, 65, 50) | 63 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 102 (BL n=80, 66, 65, 50) | 17 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 102 (BL n=43,45,49, 21) | 11 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 102 (BL n=43,45,49, 21) | 32 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 154 (BL n=60, 46, 53, 34) | 48 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 154 (BL n=60, 46, 53, 34) | 12 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 154 (BL n=26, 34, 34, 16) | 10 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 154 (BL n=26,34,34,16) | 16 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 206 (BL n=48, 31, 42, 24) | 39 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 206 (BL n=48, 31, 42, 24) | 9 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 206 (BL n=20, 25, 28, 13) | 9 participants |
| Saxagliptin 2.5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 206 (BL n=20,25,28,13) | 11 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 206 (BL n=20,25,28,13) | 16 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 102 (BL n=80, 66, 65, 50) | 55 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 12(BL n=69, 66, 70, 58) | 44 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 206 (BL n=20, 25, 28, 13) | 9 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 206 (BL n=48, 31, 42, 24) | 4 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 102 (BL n=80, 66, 65, 50) | 11 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 76 (BL n=94, 89, 92, 81) | 74 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 154 (BL n=60, 46, 53, 34) | 36 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 24 (BL n=96, 87, 83, 77) | 8 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 102 (BL n=43,45,49, 21) | 14 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 12 (BL n=69, 66, 70, 58) | 22 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 102 (BL n=43,45,49, 21) | 31 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 206 (BL n=48, 31, 42, 24) | 27 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 76 (BL n=94, 89, 92, 81) | 15 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 154 (BL n=26,34,34,16) | 21 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 12 (BL n=108,109,104,104) | 11 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 24(BL n=58, 58, 56, 41) | 36 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 76 (BL n=51, 52, 59, 44) | 18 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 24 (BL n=58, 58, 56, 41) | 22 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 154 (BL n=26, 34, 34, 16) | 13 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 12(BL n=108, 109, 104, 104) | 98 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 76 (BL n=51,52,59,44) | 34 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 24 (BL n=96, 87, 83, 77) | 79 participants |
| Saxagliptin 5 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 154 (BL n=60, 46, 53, 34) | 10 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 76 (BL n=51, 52, 59, 44) | 18 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 24 (BL n=58, 58, 56, 41) | 15 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 24(BL n=58, 58, 56, 41) | 41 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 76 (BL n=94, 89, 92, 81) | 73 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 76 (BL n=94, 89, 92, 81) | 19 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 206 (BL n=48, 31, 42, 24) | 32 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 154 (BL n=26,34,34,16) | 22 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 76 (BL n=51,52,59,44) | 41 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 102 (BL n=80, 66, 65, 50) | 48 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 102 (BL n=80, 66, 65, 50) | 17 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 206 (BL n=48, 31, 42, 24) | 10 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 102 (BL n=43,45,49, 21) | 14 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 102 (BL n=43,45,49, 21) | 35 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 206 (BL n=20,25,28,13) | 17 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 154 (BL n=60, 46, 53, 34) | 37 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 154 (BL n=60, 46, 53, 34) | 16 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 206 (BL n=20, 25, 28, 13) | 11 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 12(BL n=108, 109, 104, 104) | 94 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 12 (BL n=108,109,104,104) | 10 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 154 (BL n=26, 34, 34, 16) | 12 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 12 (BL n=69, 66, 70, 58) | 22 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 12(BL n=69, 66, 70, 58) | 48 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 24 (BL n=96, 87, 83, 77) | 70 participants |
| Saxagliptin 10 mg + Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 24 (BL n=96, 87, 83, 77) | 13 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 206 (BL n=20, 25, 28, 13) | 7 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 206 (BL n=48, 31, 42, 24) | 16 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 24(BL n=58, 58, 56, 41) | 27 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 12(BL n=108, 109, 104, 104) | 82 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 76 (BL n=51, 52, 59, 44) | 13 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 76 (BL n=94, 89, 92, 81) | 21 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 24 (BL n=96, 87, 83, 77) | 16 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 12 (BL n=108,109,104,104) | 22 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 24 (BL n=96, 87, 83, 77) | 61 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 76 (BL n=94, 89, 92, 81) | 60 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 154 (BL n=26,34,34,16) | 9 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 12 (BL n=69, 66, 70, 58) | 12 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 206 (BL n=48, 31, 42, 24) | 8 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 102 (BL n=43,45,49, 21) | 6 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 154 (BL n=26, 34, 34, 16) | 7 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 102 (BL n=43,45,49, 21) | 15 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 206 (BL n=20,25,28,13) | 6 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 102 (BL n=80, 66, 65, 50) | 9 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Normal Week 24 (BL n=58, 58, 56, 41) | 14 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 154 (BL n=60, 46, 53, 34) | 26 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Normal Week 102 (BL n=80, 66, 65, 50) | 41 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 76 (BL n=51,52,59,44) | 31 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Abnormal BL, Abnormal Week 12(BL n=69, 66, 70, 58) | 46 participants |
| Placebo+ Metformin | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | Normal BL, Abnormal Week 154 (BL n=60, 46, 53, 34) | 8 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: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.
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 + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >10 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | 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 + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hematocrit < 0.75 x pre-Rx (n=189, 190, 181, 179) | 2 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >10 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum Low (*) (n=190,190,181,179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Fasting<50mg/dL(n=189,189,181,179) | 2 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets < 50 x 10^9 c/L (n=189, 188, 181, 178) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >1.5xULN (n=190,190,181,179) | 2 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >20 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >3 x ULN (n=190, 190, 181, 179) | 4 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets > 1.5 x ULN (n=189, 188, 181, 178) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Protein Urine, >=2-4 (n=187, 189, 180, 178) | 7 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatinine >2.5 mg/dL (n=190,190,181,179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | 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 + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Leukocytes < 2 x 1000 c/µL (n=189, 190, 181, 179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2mg/dL (n=190,190,181,179) | 2 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium,Serum Low (*) (n=190,190,181,179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatine Kinase > 5 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Neutrophils+Bands <1x1000 c/µL (n=189,190,181,179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2xULN (n=190,190,181,179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride > 120 mEq/L (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | 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 + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Eosinophils >0.9x1000 c/µL (n=189, 190, 181, 179) | 12 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Unspec.<50mg/dL(n=192,191,181,179) | 19 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Blood Urine, >=2-4 (n=187, 189, 180, 178) | 17 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >5 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Lymphocytes <=0.75x1000 c/µL (n=189,190,181,179) | 3 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium,Serum High (*) (n=190,190,181,179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum High (n=190,190,181,179) | 4 participants |
| Saxagliptin 2.5 mg + Metformin | 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 + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >3 x pre-Rx and >ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | BUN >2 x pre-Rx and >ULN (n=190,190,181,179) | 12 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Red Blood Cells Urine >=2-4 (n=175,176,162,166) | 28 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >20 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >1.5 x ULN (n=190, 190, 181, 179) | 3 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride < 90 mEq/L (n=190, 190, 181, 179) | 2 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Albumin < 0.9 LLN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | 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 + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >3 x ULN (n=190, 190, 181, 179) | 6 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Fasting>500mg/dL(n=189,189,181,179) | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | White Blood Cells Urine >=2-4 (n=175,176,162,166) | 43 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hemoglobin < 8 g/dL (n=189, 190, 181, 179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >5 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 2.5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Unspec.>500mg/dL(n=192,191,181,179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >5 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >10 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | BUN >2 x pre-Rx and >ULN (n=190,190,181,179) | 9 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | White Blood Cells Urine >=2-4 (n=175,176,162,166) | 38 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >20 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2xULN (n=190,190,181,179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >3 x ULN (n=190, 190, 181, 179) | 4 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Uric Acid > 1.5 x ULN (n=0, 0, 0, 0) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >5 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum Low (*) (n=190,190,181,179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >1.5xULN (n=190,190,181,179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >10 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Unspec.<50mg/dL(n=192,191,181,179) | 7 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >20 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2mg/dL (n=190,190,181,179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Protein Urine, >=2-4 (n=187, 189, 180, 178) | 9 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatine Kinase > 5 x ULN (n=190, 190, 181, 179) | 2 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Blood Urine, >=2-4 (n=187, 189, 180, 178) | 21 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Fasting>500mg/dL(n=189,189,181,179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Red Blood Cells Urine >=2-4 (n=175,176,162,166) | 27 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hemoglobin < 8 g/dL (n=189, 190, 181, 179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride < 90 mEq/L (n=190, 190, 181, 179) | 3 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Fasting<50mg/dL(n=189,189,181,179) | 3 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hematocrit < 0.75 x pre-Rx (n=189, 190, 181, 179) | 5 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets < 50 x 10^9 c/L (n=189, 188, 181, 178) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium,Serum High (*) (n=190,190,181,179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets > 1.5 x ULN (n=189, 188, 181, 178) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium,Serum Low (*) (n=190,190,181,179) | 2 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Leukocytes < 2 x 1000 c/µL (n=189, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Neutrophils+Bands <1x1000 c/µL (n=189,190,181,179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Eosinophils >0.9x1000 c/µL (n=189, 190, 181, 179) | 12 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride > 120 mEq/L (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Lymphocytes <=0.75x1000 c/µL (n=189,190,181,179) | 4 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >3 x pre-Rx and >ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Unspec.>500mg/dL(n=192,191,181,179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >1.5 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >3 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Albumin < 0.9 LLN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatinine >2.5 mg/dL (n=190,190,181,179) | 1 participants |
| Saxagliptin 5 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum High (n=190,190,181,179) | 5 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium,Serum High (*) (n=190,190,181,179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum Low (*) (n=190,190,181,179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum High (n=190,190,181,179) | 5 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatine Kinase > 5 x ULN (n=190, 190, 181, 179) | 3 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride < 90 mEq/L (n=190, 190, 181, 179) | 3 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride > 120 mEq/L (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Albumin < 0.9 LLN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Uric Acid > 1.5 x ULN (n=0, 0, 0, 0) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Protein Urine, >=2-4 (n=187, 189, 180, 178) | 13 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Blood Urine, >=2-4 (n=187, 189, 180, 178) | 18 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Red Blood Cells Urine >=2-4 (n=175,176,162,166) | 22 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hemoglobin < 8 g/dL (n=189, 190, 181, 179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hematocrit < 0.75 x pre-Rx (n=189, 190, 181, 179) | 5 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets < 50 x 10^9 c/L (n=189, 188, 181, 178) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets > 1.5 x ULN (n=189, 188, 181, 178) | 4 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Leukocytes < 2 x 1000 c/µL (n=189, 190, 181, 179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Neutrophils+Bands <1x1000 c/µL (n=189,190,181,179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Eosinophils >0.9x1000 c/µL (n=189, 190, 181, 179) | 18 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Lymphocytes <=0.75x1000 c/µL (n=189,190,181,179) | 4 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >3 x pre-Rx and >ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >1.5 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >3 x ULN (n=190, 190, 181, 179) | 3 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >5 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >10 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | White Blood Cells Urine >=2-4 (n=175,176,162,166) | 26 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >20 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >3 x ULN (n=190, 190, 181, 179) | 4 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >5 x ULN (n=190, 190, 181, 179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >10 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >20 x ULN (n=190, 190, 181, 179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2mg/dL (n=190,190,181,179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >1.5xULN (n=190,190,181,179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2xULN (n=190,190,181,179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | BUN >2 x pre-Rx and >ULN (n=190,190,181,179) | 6 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatinine >2.5 mg/dL (n=190,190,181,179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Fasting<50mg/dL(n=189,189,181,179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Fasting>500mg/dL(n=189,189,181,179) | 0 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Unspec.<50mg/dL(n=192,191,181,179) | 9 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Unspec.>500mg/dL(n=192,191,181,179) | 1 participants |
| Saxagliptin 10 mg + Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium,Serum Low (*) (n=190,190,181,179) | 4 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | BUN >2 x pre-Rx and >ULN (n=190,190,181,179) | 9 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >5 x ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >3 x ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride > 120 mEq/L (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatinine >2.5 mg/dL (n=190,190,181,179) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >1.5 x ULN (n=190, 190, 181, 179) | 3 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >3 x pre-Rx and >ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum Low (*) (n=190,190,181,179) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Lymphocytes <=0.75x1000 c/µL (n=189,190,181,179) | 2 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Eosinophils >0.9x1000 c/µL (n=189, 190, 181, 179) | 9 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Unspec.>500mg/dL(n=192,191,181,179) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Neutrophils+Bands <1x1000 c/µL (n=189,190,181,179) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Leukocytes < 2 x 1000 c/µL (n=189, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride < 90 mEq/L (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets > 1.5 x ULN (n=189, 188, 181, 178) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets < 50 x 10^9 c/L (n=189, 188, 181, 178) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatine Kinase > 5 x ULN (n=190, 190, 181, 179) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hematocrit < 0.75 x pre-Rx (n=189, 190, 181, 179) | 2 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hemoglobin < 8 g/dL (n=189, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium,Serum High (*) (n=190,190,181,179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Fasting<50mg/dL(n=189,189,181,179) | 3 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Red Blood Cells Urine >=2-4 (n=175,176,162,166) | 20 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Blood Urine, >=2-4 (n=187, 189, 180, 178) | 13 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium,Serum Low (*) (n=190,190,181,179) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Fasting>500mg/dL(n=189,189,181,179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Protein Urine, >=2-4 (n=187, 189, 180, 178) | 12 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >20 x ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Uric Acid > 1.5 x ULN (n=0, 0, 0, 0) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2mg/dL (n=190,190,181,179) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >10 x ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >5 x ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum High (n=190,190,181,179) | 7 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >1.5xULN (n=190,190,181,179) | 1 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >3 x ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >20 x ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Unspec.<50mg/dL(n=192,191,181,179) | 9 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2xULN (n=190,190,181,179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | White Blood Cells Urine >=2-4 (n=175,176,162,166) | 28 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >10 x ULN (n=190, 190, 181, 179) | 0 participants |
| Placebo+ Metformin | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Albumin < 0.9 LLN (n=190, 190, 181, 179) | 0 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.
Time frame: AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 AE | 177 participants |
| Saxagliptin 2.5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Discontinuations Due to SAEs | 4 participants |
| Saxagliptin 2.5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 Related SAE | 0 participants |
| Saxagliptin 2.5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 Related AE | 53 participants |
| Saxagliptin 2.5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Discontinuations Due to AEs | 11 participants |
| Saxagliptin 2.5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Deaths | 1 participants |
| Saxagliptin 2.5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 SAE | 23 participants |
| Saxagliptin 5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Discontinuations Due to SAEs | 6 participants |
| Saxagliptin 5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 SAE | 27 participants |
| Saxagliptin 5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Deaths | 0 participants |
| Saxagliptin 5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 Related SAE | 3 participants |
| Saxagliptin 5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Discontinuations Due to AEs | 18 participants |
| Saxagliptin 5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 Related AE | 57 participants |
| Saxagliptin 5 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 AE | 155 participants |
| Saxagliptin 10 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 SAE | 22 participants |
| Saxagliptin 10 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 AE | 161 participants |
| Saxagliptin 10 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 Related AE | 65 participants |
| Saxagliptin 10 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Deaths | 1 participants |
| Saxagliptin 10 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 Related SAE | 1 participants |
| Saxagliptin 10 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Discontinuations Due to SAEs | 6 participants |
| Saxagliptin 10 mg + Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Discontinuations Due to AEs | 13 participants |
| Placebo+ Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Deaths | 2 participants |
| Placebo+ Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Discontinuations Due to AEs | 9 participants |
| Placebo+ Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | Discontinuations Due to SAEs | 0 participants |
| Placebo+ Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 Related AE | 56 participants |
| Placebo+ Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 AE | 142 participants |
| Placebo+ Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 Related SAE | 1 participants |
| Placebo+ Metformin | Overall Summary of Adverse Events During ST+LT Treatment Period | At Least 1 SAE | 15 participants |