| Outcome Measures: |
Primary: Baseline Hemoglobin A1c (HbA1c), HbA1c is measured as percent., Baseline|Change From Baseline in HbA1c at Week 12, HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward \[LOCF\])., Baseline and Week 12 | Secondary: Change From Baseline in HbA1C at Week 2, HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF)., Baseline and Week 2|Change From Baseline in HbA1c at Week 4, HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF)., Baseline and Week 4|Change From Baseline in HbA1c at Week 8, HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF)., Baseline and Week 8|Baseline Body Weight, Baseline|Percent Change From Baseline in Body Weight at Week 12, The percent change from baseline is the (\[Week 12 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF)., Baseline and Week 12|Percent Change From Baseline in Body Weight at Week 2, The percent change from baseline is the (\[Week 2 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF)., Baseline and Week 2|Percent Change From Baseline in Body Weight at Week 4, The percent change from baseline is the (\[Week 4 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF)., Baseline and Week 4|Percent Change From Baseline in Body Weight at Week 8, The percent change from baseline is the (\[Week 8 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF)., Baseline and Week 8|Baseline Systolic Blood Pressure, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed., Baseline|Change From Baseline in Systolic Blood Pressure at Week 12, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF)., Baseline and Week 12|Change From Baseline in Systolic Blood Pressure at Week 2, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF)., Baseline and Week 2|Change From Baseline in Systolic Blood Pressure at Week 4, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF)., Baseline and Week 4|Change From Baseline in Systolic Blood Pressure at Week 8, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF)., Baseline and Week 8|Baseline Diastolic Blood Pressure, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed., Baseline|Change From Baseline in Diastolic Blood Pressure at Week 12, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF)., Baseline and Week 12|Change From Baseline in Diastolic Blood Pressure at Week 2, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF)., Baseline and Week 2|Change From Baseline in Diastolic Blood Pressure at Week 4, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF)., Baseline and Week 4|Change From Baseline in Diastolic Blood Pressure at Week 8, Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF)., Baseline and Week 8|Baseline Fasting Plasma Glucose, Laboratory measurements were performed after an overnight fast ≥8 hours in duration., Baseline|Change From Baseline in Fasting Plasma Glucose at Week 12, The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration., Baseline and Week 12|Change From Baseline in Fasting Plasma Glucose at Week 2, The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration., Baseline and Week 2|Change From Baseline in Fasting Plasma Glucose at Week 4, The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration., Baseline and Week 4|Change From Baseline in Fasting Plasma Glucose at Week 8, The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration., Baseline and Week 8|Percentage of Participants Achieving HbA1c <7% at Week 12, Laboratory measurements were performed after an overnight fast ≥8 hours in duration., Week 12|Percentage of Participants Achieving HbA1C <6.5% at Week 12, Laboratory measurements were performed after an overnight fast ≥8 hours in duration., Week 12|Number of Participants Who Experienced an Advere Event (AE), An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin., Up to 98 days|Number of Participants Who Discontinued Study Medication Due to an AE, An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication., Up to 84 days
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