Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.
Interventions
DRUGSaxagliptin plus metformin IR
Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
DRUGPlacebo plus metformin IR
Tablets, Oral, Placebo, Twice daily, 12 weeks
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * 18-78 years of age * Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks * A1C: 7-10% * C-peptide: ≥ 0.8 ng/mL * Body mass index (BMI): ≤45 kg/m\^2
Exclusion criteria
* Women of childbearing potential unable or unwilling to use acceptable birth control * Women who are pregnant or breastfeeding * Fasting plasma glucose (FPG) \>270 mg/dL * Significant cardiovascular history * Symptoms of poorly controlled diabetes * History of diabetic ketoacidosis or hyperosmolar nonketotic coma * Insulin therapy within one year of screening * Cardiovascular even within the prior 6 months * New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction \<=40% * Significant history of renal or hepatic disease * History of a psychiatric disorder, alcohol or drug abuse within the previous year * Treatment with potent CYP3A4 inhibitors or inducers * Immunocompromised participants * Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 | Baseline, Week 12 | Mean change was adjusted for baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline, Week 12 | Mean change was adjusted for baseline. |
| Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12 | Week 12 | Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.) |
| Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12 | Week 12 | Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Week 4, Week 8, Week 12 | Baseline values reference the measurement for the cohort of participants evaluated at the given time point. |
| Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | Baseline, Week 4, Week 8, Week 12 | Baseline values reference the measurement for the cohort of participants evaluated at the given time point. |
| Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period. | AE = any new untoward medical occurrence/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. Treatment-related=Possible, Probable, or Certain relationship to drug. |
| Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Baseline, Week 12 | Marked abnormality criteria were urine protein: if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4; urine blood: if pre-Rx=0, use \>=2, if pre-Rx=0.5 or 1, use \>=3, if pre-Rx=2, use \>=4; Urine red blood cell count (RBC): if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4; urine white blood cell count (WBC): if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4. |
| Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Baseline, Week 12 | 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. ULN=upper limit of normal; LLN=lower limit of normal. |
| Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period | Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period. | Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. |
| Participants With Confirmed Hypoglycemia | Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period. | Confirmed hypoglycemia was defined by a fingerstick glucose value \<= 50 mg/dL with associated hypoglycemia symptoms. |
| Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Baseline, Week 12 | Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12. |
Countries
Germany, Hungary, Puerto Rico, United States
Participant flow
Recruitment details
Participants at 43 sites in 4 countries (25 sites in the United States \[US\], 9 in Germany, 5 in Hungary, and 4 in Puerto Rico) received study medication and participated in this study.
Pre-assignment details
Of the 166 subjects who entered the lead-in period, 6 discontinued: 3 withdrawal of consent, 1 poor/noncompliance, 1 adverse event (AE; abdominal pain secondary to partial small bowel obstruction), and 1 elevated liver enzymes that did not meet study exclusion criteria but was discontinued by the investigator.
Participants by arm
| Arm | Count |
|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID). | 74 |
| Placebo + Metformin IR 2.5 mg placebo tablets PO BID plus flexible metformin IR dose. | 86 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Poor/Noncompliance | 2 | 2 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Total | Placebo + Metformin IR |
|---|---|---|---|
| Age, Continuous | 53.90 years STANDARD_DEVIATION 10.35 | 55.4 years STANDARD_DEVIATION 10.2 | 56.60 years STANDARD_DEVIATION 9.97 |
| Mean Body Mass Index (BMI) | 33.68 kg / m^2 STANDARD_DEVIATION 5.94 | 33.05 kg / m^2 STANDARD_DEVIATION 6.08 | 32.51 kg / m^2 STANDARD_DEVIATION 6.18 |
| Mean Duration of Type 2 Diabetes Mellitus | 5.81 Years STANDARD_DEVIATION 6.37 | 6.00 Years STANDARD_DEVIATION 5.3 | 6.17 Years STANDARD_DEVIATION 4.21 |
| Mean Height | 168.38 cm STANDARD_DEVIATION 9.56 | 168.05 cm STANDARD_DEVIATION 9.23 | 167.77 cm STANDARD_DEVIATION 8.99 |
| Mean Metformin Dose at Baseline | 1911.5 mg STANDARD_DEVIATION 376.59 | 1881.6 mg STANDARD_DEVIATION 352.38 | 1855.8 mg STANDARD_DEVIATION 330.19 |
| Mean Weight | 95.85 kg STANDARD_DEVIATION 21.4 | 93.64 kg STANDARD_DEVIATION 20.63 | 91.74 kg STANDARD_DEVIATION 19.87 |
| Participant Body Mass Index < 30 kg / m^2 | 19 Participants | 54 Participants | 35 Participants |
| Participant Body Mass Index >= 30 kg / m^2 | 55 Participants | 106 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 11 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 64 Participants | 144 Participants | 80 Participants |
| Region of Enrollment Germany | 9 participants | 21 participants | 12 participants |
| Region of Enrollment Hungary | 8 participants | 16 participants | 8 participants |
| Region of Enrollment Puerto Rico | 8 participants | 18 participants | 10 participants |
| Region of Enrollment United States | 49 participants | 105 participants | 56 participants |
| Sex: Female, Male Female | 34 Participants | 75 Participants | 41 Participants |
| Sex: Female, Male Male | 40 Participants | 85 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 86 | 0 / 74 |
| serious Total, serious adverse events | 1 / 86 | 1 / 74 |
Outcome results
Primary
Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
Mean change was adjusted for baseline.
Time frame: Baseline, Week 12
Population: Randomized participants with both a baseline value and post-baseline value (up to Week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 | Baseline | 7.92 Percentage of glycosylated hemoglobins | Standard Error 0.11 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 | Adjusted Mean Change From Baseline | -0.56 Percentage of glycosylated hemoglobins | Standard Error 0.09 |
| Placebo + Metformin IR | Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 | Baseline | 7.97 Percentage of glycosylated hemoglobins | Standard Error 0.09 |
| Placebo + Metformin IR | Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 | Adjusted Mean Change From Baseline | -0.22 Percentage of glycosylated hemoglobins | Standard Error 0.08 |
p-value: 0.006395% CI: [-0.58, -0.1]ANCOVA
Secondary
Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)
Mean change was adjusted for baseline.
Time frame: Baseline, Week 12
Population: Randomized participants with a measurement at the specified timepoint with Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) | Mean Baseline | 164.22 mg / dL | Standard Error 5.512 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) | Adjusted Mean Change from Baseline | -13.73 mg / dL | Standard Error 4.51 |
| Placebo + Metformin IR | Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) | Adjusted Mean Change from Baseline | -4.22 mg / dL | Standard Error 4.2 |
| Placebo + Metformin IR | Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) | Mean Baseline | 161.25 mg / dL | Standard Error 4.624 |
p-value: 0.124895% CI: [-21.68, 2.66]ANCOVA
Secondary
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12
Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Time frame: Week 12
Population: Randomized participants with measurement at timepoint with LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12 | 24.6 Percentage of Participants |
| Placebo + Metformin IR | Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12 | 10.7 Percentage of Participants |
95% CI: [3, 24.7]
Secondary
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12
Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Time frame: Week 12
Population: Randomized participants with measurement at timepoint with LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12 | 37.5 Percentage of Participants |
| Placebo + Metformin IR | Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12 | 24.2 Percentage of Participants |
95% CI: [1.1, 25.4]
Other Pre-specified
Baseline and Mean Change From Baseline in Participant Heart Rate (HR)
Baseline values reference the measurement for the cohort of participants evaluated at the given time point.
Time frame: Baseline, Week 4, Week 8, Week 12
Population: All treated participants. n= number of participants with measurement at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | Baseline HR for Week 4 cohort (n=74, 84) | 73.45 mm Hg | Standard Error 1.072 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | HR Change From Baseline at Week 4 (n=74, 84) | 0.97 mm Hg | Standard Error 0.881 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | Baseline HR for Week 8 cohort (n=70, 81) | 73.51 mm Hg | Standard Error 1.091 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | HR Change From Baseline at Week 8 (n=70, 81) | 2.70 mm Hg | Standard Error 0.914 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | Baseline HR for Week 12 cohort (n=66, 77) | 73.71 mm Hg | Standard Error 1.142 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | HR Change From Baseline at Week 12 (n=66, 77) | 0.61 mm Hg | Standard Error 1.061 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | Baseline HR for Week 12 cohort (n=66, 77) | 73.55 mm Hg | Standard Error 1.035 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | Baseline HR for Week 4 cohort (n=74, 84) | 73.77 mm Hg | Standard Error 0.968 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | HR Change From Baseline at Week 8 (n=70, 81) | 0.28 mm Hg | Standard Error 0.727 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | HR Change From Baseline at Week 4 (n=74, 84) | 1.18 mm Hg | Standard Error 0.778 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | HR Change From Baseline at Week 12 (n=66, 77) | 0.60 mm Hg | Standard Error 0.866 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Heart Rate (HR) | Baseline HR for Week 8 cohort (n=70, 81) | 73.56 mm Hg | Standard Error 0.99 |
Other Pre-specified
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline values reference the measurement for the cohort of participants evaluated at the given time point.
Time frame: Baseline, Week 4, Week 8, Week 12
Population: All treated participants. n= number of participants with measurement at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline SBP for Week 4 cohort (n=74, 84) | 128.89 mm Hg | Standard Error 1.67 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline DBP for Week 4 cohort (n=74, 84) | 78.99 mm Hg | Standard Error 1.07 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change From Baseline at Week 4 (n=74, 84) | -0.47 mm Hg | Standard Error 1.43 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change From Baseline at Week 4 (n=74, 84) | -0.81 mm Hg | Standard Error 0.84 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline SBP for Week 8 cohort (n=70, 81) | 128.33 mm Hg | Standard Error 1.67 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline DBP for Week 8 cohort (n=70, 81) | 78.87 mm Hg | Standard Error 1.08 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change From Baseline at Week 8 (n=70, 81) | 0.60 mm Hg | Standard Error 1.66 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change From Baseline at Week 8 (n=70, 81) | 0.37 mm Hg | Standard Error 0.94 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline SBP for Week 12 cohort (n=66, 77) | 128.18 mm Hg | Standard Error 1.76 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline DBP for Week 12 cohort (n=66, 77) | 78.85 mm Hg | Standard Error 1.13 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change From Baseline at Week 12 (n=66, 77) | 1.59 mm Hg | Standard Error 1.51 |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change From Baseline at Week 12 (n=66, 77) | 1.03 mm Hg | Standard Error 0.75 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change From Baseline at Week 12 (n=66, 77) | 0.83 mm Hg | Standard Error 1.26 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline SBP for Week 4 cohort (n=74, 84) | 127.57 mm Hg | Standard Error 1.53 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change From Baseline at Week 8 (n=70, 81) | -0.43 mm Hg | Standard Error 1.48 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline DBP for Week 4 cohort (n=74, 84) | 77.07 mm Hg | Standard Error 1.05 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline DBP for Week 12 cohort (n=66, 77) | 77.23 mm Hg | Standard Error 1.06 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change From Baseline at Week 4 (n=74, 84) | 0.17 mm Hg | Standard Error 1.16 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change From Baseline at Week 8 (n=70, 81) | 0.86 mm Hg | Standard Error 0.93 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change From Baseline at Week 4 (n=74, 84) | 0.95 mm Hg | Standard Error 0.86 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change From Baseline at Week 12 (n=66, 77) | 1.29 mm Hg | Standard Error 0.85 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline SBP for Week 8 cohort (n=70, 81) | 127.60 mm Hg | Standard Error 1.57 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline SBP for Week 12 cohort (n=66, 77) | 127.38 mm Hg | Standard Error 1.56 |
| Placebo + Metformin IR | Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline DBP for Week 8 cohort (n=70, 81) | 77.32 mm Hg | Standard Error 1.03 |
Other Pre-specified
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
AE = any new untoward medical occurrence/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. Treatment-related=Possible, Probable, or Certain relationship to drug.
Time frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | Deaths | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | At Least 1 Related SAE | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | At Least 1 Related AE | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | Discontinued Due to SAEs | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | At Least 1 SAE | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | Discontinued Due to AEs | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | At Least 1 AE | 19 Participants |
| Placebo + Metformin IR | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | Discontinued Due to AEs | 0 Participants |
| Placebo + Metformin IR | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | At Least 1 AE | 34 Participants |
| Placebo + Metformin IR | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | At Least 1 Related AE | 3 Participants |
| Placebo + Metformin IR | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | Deaths | 0 Participants |
| Placebo + Metformin IR | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | At Least 1 SAE | 1 Participants |
| Placebo + Metformin IR | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | At Least 1 Related SAE | 0 Participants |
| Placebo + Metformin IR | Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary | Discontinued Due to SAEs | 0 Participants |
Other Pre-specified
Participant Electrocardiogram (ECG) Status at Baseline and Week 12
Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12.
Time frame: Baseline, Week 12
Population: All treated participants, excluding those with missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Baseline Normal | 36 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Baseline Abnormal | 35 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Week 12 Normal | 39 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Week 12 Abnormal | 32 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Shifted Normal to Abnormal | 5 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Shifted Abnormal to Normal | 8 Participants |
| Placebo + Metformin IR | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Shifted Normal to Abnormal | 4 Participants |
| Placebo + Metformin IR | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Baseline Normal | 42 Participants |
| Placebo + Metformin IR | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Week 12 Abnormal | 28 Participants |
| Placebo + Metformin IR | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Baseline Abnormal | 36 Participants |
| Placebo + Metformin IR | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Shifted Abnormal to Normal | 12 Participants |
| Placebo + Metformin IR | Participant Electrocardiogram (ECG) Status at Baseline and Week 12 | Week 12 Normal | 50 Participants |
Other Pre-specified
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
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. ULN=upper limit of normal; LLN=lower limit of normal.
Time frame: Baseline, Week 12
Population: All treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Hemoglobin < 8 g/dL | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Hematocrit < 0.75 prior to dosing | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Platelets < 50 x 10^9 c/L | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Platelets > 1.5 x ULN | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Leukocytes < 2 x 10^3 c/uL | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Neutrophils < 1 x 10^3 c/uL | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Eosinophils > 0.9 x 10^3 c/uL | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Lymphocytes <= 0.75 x 10^3 c/uL | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Alkaline Phosphatase >3x prior to dosing and > ULN | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Aspartate Aminotransferase > 3x ULN | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Aspartate Aminotransferase > 5x ULN | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Alanine Aminotransferase > 3x ULN | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Alanine Aminotransferase > 5x ULN | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Total Bilirubin > 2 mg/dL | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Total Bilirubin > 1.5x ULN | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Blood Urea Nitrogen > 2x prior to dosing and > ULN | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Creatinine > 2.5 mg/dL | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Sodium <0.9x pre-Rx and <= 130 mEq/ | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Sodium >1.1x pre-Rx and >= 150 mEq/L | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Potassium <=0.8x pre-Rx and <= 3.2 mEq/L | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Potassium >=1.2x pre-Rx and >= 6.0 mEq/L | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Chloride <90 mEq/L | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Chloride > 120 mEq/L | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Albumin <0.9x LLN, or if pre-Rx<LLN use <0.75x | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Creatinine Kinase > 5x ULN | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Fasting Plasma Glucose < 50 mg/dL | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Fasting Plasma Glucose > 500 mg/dL | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Plasma Glucose Unspecified < 50 mg/dL | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Plasma Glucose Unspecified > 500 mg/dL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Total Bilirubin > 1.5x ULN | 1 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Hemoglobin < 8 g/dL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Fasting Plasma Glucose < 50 mg/dL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Hematocrit < 0.75 prior to dosing | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Blood Urea Nitrogen > 2x prior to dosing and > ULN | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Platelets < 50 x 10^9 c/L | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Chloride > 120 mEq/L | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Platelets > 1.5 x ULN | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Creatinine > 2.5 mg/dL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Leukocytes < 2 x 10^3 c/uL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Plasma Glucose Unspecified < 50 mg/dL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Neutrophils < 1 x 10^3 c/uL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Sodium <0.9x pre-Rx and <= 130 mEq/ | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Eosinophils > 0.9 x 10^3 c/uL | 2 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Albumin <0.9x LLN, or if pre-Rx<LLN use <0.75x | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Lymphocytes <= 0.75 x 10^3 c/uL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Sodium >1.1x pre-Rx and >= 150 mEq/L | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Alkaline Phosphatase >3x prior to dosing and > ULN | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Fasting Plasma Glucose > 500 mg/dL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Aspartate Aminotransferase > 3x ULN | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Potassium <=0.8x pre-Rx and <= 3.2 mEq/L | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Aspartate Aminotransferase > 5x ULN | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Creatinine Kinase > 5x ULN | 1 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Alanine Aminotransferase > 3x ULN | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Potassium >=1.2x pre-Rx and >= 6.0 mEq/L | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Alanine Aminotransferase > 5x ULN | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Plasma Glucose Unspecified > 500 mg/dL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Total Bilirubin > 2 mg/dL | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria | Serum Chloride <90 mEq/L | 0 Participants |
Other Pre-specified
Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria
Marked abnormality criteria were urine protein: if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4; urine blood: if pre-Rx=0, use \>=2, if pre-Rx=0.5 or 1, use \>=3, if pre-Rx=2, use \>=4; Urine red blood cell count (RBC): if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4; urine white blood cell count (WBC): if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4.
Time frame: Baseline, Week 12
Population: All treated participants. N = number of participants analyzed and n = the number of participants with values available for each specific measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Urine Protein (n=74, 84) | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Urine Blood (n=74, 84) | 1 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Urine Red Blood Cells (n=7, 10) | 0 Participants |
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Urine White Blood Cells (n=16, 18) | 2 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Urine White Blood Cells (n=16, 18) | 2 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Urine Protein (n=74, 84) | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Urine Red Blood Cells (n=7, 10) | 0 Participants |
| Placebo + Metformin IR | Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria | Urine Blood (n=74, 84) | 1 Participants |
Other Pre-specified
Participants With Confirmed Hypoglycemia
Confirmed hypoglycemia was defined by a fingerstick glucose value \<= 50 mg/dL with associated hypoglycemia symptoms.
Time frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants With Confirmed Hypoglycemia | 0 Participants |
| Placebo + Metformin IR | Participants With Confirmed Hypoglycemia | 1 Participants |
Other Pre-specified
Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period
Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.
Time frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.
Population: All treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 2.5 mg + Metformin Immediate Release (IR) | Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period | 4 Participants |
| Placebo + Metformin IR | Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period | 1 Participants |