| Outcome Measures: |
Primary: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12, Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 12 | Secondary: Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12, The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 12|Change From Baseline in Body Weight at Week 12, Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 12|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12, Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 12|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12, The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Week 12|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12, The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Week 12|Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period, Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: \>270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: \>240 mg/dL (13.3 mmol/L). For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline up to Week 12 | Other: Change From Baseline in Glucose Excursion at Week 12, Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 12|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12, The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 12|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia, Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available., First dose of study drug up to 3 days after the last dose administration
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| Locations: |
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, 08807, United States|Sanofi-Aventis Administrative Office, Diegem, Belgium|Sanofi-Aventis Administrative Office, Mumbai, India|Sanofi-Aventis Administrative Office, Natanya, Israel|Sanofi-Aventis Administrative Office, Tokyo, Japan|Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of|Sanofi-Aventis Administrative Office, Mexico, Mexico|Sanofi-Aventis Administrative Office, Warszawa, Poland|Sanofi-Aventis Administrative Office, Bucuresti, Romania|Sanofi-Aventis Administrative Office, Moscow, Russian Federation|Sanofi-Aventis Administrative Office, Megrine, Tunisia|Sanofi-Aventis Administrative Office, Kiev, Ukraine
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