| Outcome Measures: |
Primary: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24, Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24 | Secondary: Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24, The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24, Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|Change From Baseline in Body Weight at Week 24, Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|Change From Baseline in Total Insulin Dose at Week 24, Change was calculated for total insulin dose by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24, The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24, The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period, Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) 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 (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \> 8.5%. 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 24 | Other: Change From Baseline in Glucose Excursion at Week 24, Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24, The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 24|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 for up to 125 weeks
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| Locations: |
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, 08807, United States|Sanofi-Aventis Administrative Office, Sao Paulo, Brazil|Sanofi-Aventis Administrative Office, Laval, Canada|Sanofi-Aventis Administrative Office, Santiago, Chile|Sanofi-Aventis Administrative Office, Cairo, Egypt|Sanofi-Aventis Administrative Office, Paris, France|Sanofi-Aventis Administrative Office, Berlin, Germany|Sanofi-Aventis Administrative Office, Mumbai, India|Sanofi-Aventis Administrative Office, Milano, Italy|Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of|Sanofi-Aventis Administrative Office, Mexico, Mexico|Sanofi-Aventis Administrative Office, Puerto Rico, Puerto Rico|Sanofi-Aventis Administrative Office, Moscow, Russian Federation|Sanofi-Aventis Administrative Office, Istanbul, Turkey|Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom
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