Type 2 Diabetes
Conditions
Brief summary
The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes
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 who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication
Interventions
DRUGSaxagliptin
Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)
DRUGPlacebo
Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)
DRUGMetformin (blinded)
Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)
Tablets, Oral, 500-1500 mg, as needed (starting in LT)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus * Drug naive * Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0% * Fasting C-peptide ≥1.0 ng/mL * Body mass index ≤40 kg/m²
Exclusion criteria
* Recent cardiac or cerebrovascular event * Elevated serum creatinine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12 | Baseline, Week 12 | Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load \[intravenous-oral hyperglycemic clamp (180-480 minutes)\] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12 | Baseline, Week 12 | Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | 116 weeks | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing. |
| Marked Laboratory Abnormalities - During ST + LT Treatment Period | 116 weeks | A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; 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. |
Countries
United States
Participant flow
Pre-assignment details
156 participants were enrolled in the study; 110 participants failed screening; 10 subjects entered lead-in and discontinued prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Saxagliptin 5 mg Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term) | 20 |
| Placebo / Metformin Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks | 16 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 116-Week Short-term + Long-term Period | Adverse Event | 0 | 2 |
| 116-Week Short-term + Long-term Period | Lack of Efficacy | 4 | 2 |
| 116-Week Short-term + Long-term Period | Lost to Follow-up | 1 | 1 |
| 116-Week Short-term + Long-term Period | Subject Withdrew Consent | 8 | 9 |
| 12-Week Short-term Period | Subject Withdrew Consent | 3 | 1 |
Baseline characteristics
| Characteristic | Saxagliptin 5 mg | Placebo / Metformin | Total |
|---|---|---|---|
| Age, Continuous | 58 years | 55 years | 55.5 years |
| Body Mass Index (BMI) | 33.36 kg/m^2 | 32.31 kg/m^2 | 33.01 kg/m^2 |
| Race/Ethnicity, Customized Black/African American | 3 participants | 4 participants | 7 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 16 participants | 12 participants | 28 participants |
| Region of Enrollment North America | 20 participants | 16 participants | 36 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 16 | 17 / 20 |
| serious Total, serious adverse events | 2 / 16 | 1 / 20 |
Outcome results
Primary
Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12
Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load \[intravenous-oral hyperglycemic clamp (180-480 minutes)\] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Time frame: Baseline, Week 12
Population: Randomized participants with both a baseline and post-baseline value (up to Week 12).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Short Term Period: Saxagliptin 5 mg | Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12 | 15.9 Percent Change (Percentage of Baseline) |
| Short Term Period: Placebo | Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12 | -2.2 Percent Change (Percentage of Baseline) |
p-value: 0.03595% CI: [1.3, 38.7]ANCOVA
Secondary
Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12
Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Time frame: Baseline, Week 12
Population: Randomized Participants with both a baseline and post-baseline value (up to Week 12).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Short Term Period: Saxagliptin 5 mg | Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12 | 22.6 Percent Change (Percentage of Baseline) |
| Short Term Period: Placebo | Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12 | -4.1 Percent Change (Percentage of Baseline) |
p-value: 0.020495% CI: [4.2, 57.1]ANCOVA
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; BUN=blood urea nitrogen; 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: 116 weeks
Population: Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting > 500 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets > 1.5 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. < 50 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >3 x pre-Rx and >ULN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. > 500 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Protein Urine, >=2-4 (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Fasting <50 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hematocrit < 0.75 x pre-Rx (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Fasting >500 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >3 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Unspec. <50 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >5 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Unspec. >500 mg/dL (n=18, 16) | 8 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Leukocytes < 2 x 1000 c/uL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium, Serum Low (see description) (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >3 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hemoglobin < 8 g/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium, Serum High (see description) (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >5 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum Low (see description) (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Neutrophils+Bands <1x1000 c/uL (n=18, 0) | 1 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum High (see description) (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride < 90 mEq/L (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets < 50 x 10^9 c/L (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Albumin < 0.9 LLN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | BUN >2 x pre-Rx and >ULN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatine Kinase > 5 x ULN (n=18, 16) | 1 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Eosinophils >0.9x1000 c/uL (n=18, 0) | 1 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Uric Acid > 1.5 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatinine >2.5 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Blood Urine >=2-4 (n=18, 0) | 1 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride > 120 mEq/L (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Red Blood Cells Urine >=2-4 (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting < 50 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | White Blood Cells Urine >=2-4 (n=0, 0) | 2 participants |
| Short Term Period: Saxagliptin 5 mg | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Lymphocytes <=0.75x1000 c/uL (n=18, 0) | 2 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | White Blood Cells Urine >=2-4 (n=0, 0) | 1 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride > 120 mEq/L (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hemoglobin < 8 g/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Hematocrit < 0.75 x pre-Rx (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets < 50 x 10^9 c/L (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Platelets > 1.5 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Leukocytes < 2 x 1000 c/uL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Neutrophils+Bands <1x1000 c/uL (n=18, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Eosinophils >0.9x1000 c/uL (n=18, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Lymphocytes <=0.75x1000 c/uL (n=18, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALP >3 x pre-Rx and >ULN (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >5 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >3 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | ALT >5 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Bilirubin Total >2mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | BUN >2 x pre-Rx and >ULN (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatinine >2.5 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting < 50 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Fasting > 500 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. < 50 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Serum Unspec. > 500 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Fasting <50 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose,Plasma Fasting >500 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Unspec. <50 mg/dL (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Glucose, Plasma Unspec. >500 mg/dL (n=18, 16) | 9 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Protein Urine, >=2-4 (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium, Serum Low (see description) (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Sodium, Serum High (see description) (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum Low (see description) (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Potassium, Serum High (see description) (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Chloride < 90 mEq/L (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Albumin < 0.9 LLN (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Creatine Kinase > 5 x ULN (n=18, 16) | 1 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Uric Acid > 1.5 x ULN (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Blood Urine >=2-4 (n=18, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | Red Blood Cells Urine >=2-4 (n=0, 0) | 0 participants |
| Short Term Period: Placebo | Marked Laboratory Abnormalities - During ST + LT Treatment Period | AST >3 x ULN (n=0, 0) | 0 participants |
Other Pre-specified
Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the 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: 116 weeks
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Short Term Period: Saxagliptin 5 mg | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | Deaths | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | At Least 1 Related SAE | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | At Least 1 AE | 17 participants |
| Short Term Period: Saxagliptin 5 mg | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | Discontinuations Due to SAEs | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | At Least 1 SAE | 1 participants |
| Short Term Period: Saxagliptin 5 mg | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | Discontinuations Due to AEs | 0 participants |
| Short Term Period: Saxagliptin 5 mg | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | At Least 1 Related AE | 7 participants |
| Short Term Period: Placebo | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | Discontinuations Due to AEs | 2 participants |
| Short Term Period: Placebo | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | At Least 1 AE | 14 participants |
| Short Term Period: Placebo | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | At Least 1 Related AE | 6 participants |
| Short Term Period: Placebo | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | Deaths | 0 participants |
| Short Term Period: Placebo | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | At Least 1 SAE | 2 participants |
| Short Term Period: Placebo | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | At Least 1 Related SAE | 0 participants |
| Short Term Period: Placebo | Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period | Discontinuations Due to SAEs | 1 participants |