| Outcome Measures: |
Primary: Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24, Percentage of patients who met both criteria (HbA1c \<7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. 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., Week 24 | Secondary: Absolute Change From Baseline in 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 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., 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 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., Baseline, Week 24|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 the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest., 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 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., Baseline, Week 24|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 the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest., Baseline, Week 24|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24, Change was calculated for fasting plasma insulin and 2-hour post prandial plasma insulin by subtracting the baseline value from Week 24 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 the study drug or up to the introduction of rescue therapy, whichever is the earliest., Baseline, Week 24|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24, Change was calculated for fasting C-peptide and 2-hour postprandial C-peptide by subtracting the baseline value from Week 24 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., Baseline, Week 24|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24, Change was calculated for fasting glucagon and 2-hour postprandial glucagon by subtracting the baseline value from Week 24 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., Baseline, Week 24|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24, Change was calculated for fasting proinsulin and 2-hour postprandial proinsulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of the study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest., Baseline, Week 24|Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24, HOMA-IR was derived from FPG and FPI as: (FPI \[micro units per milliliter\]\*FPG \[mmol/L\]) divided by 22.5. Change was calculated for HOMA-IR by subtracting the baseline value from Week 24 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., Baseline, Week 24|Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment-Beta (HOMA-beta) at Week 24, HOMA-beta was derived from FPG and FPI as: (20\*FPI \[micro units/milliliter\]) divided by (FPG \[mmol/L\] minus 3.5). Change was calculated for HOMA-beta by subtracting the baseline value from Week 24 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., Baseline, 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 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., Week 24|Percentage of Patients Requiring Rescue Therapy During 24-Week Period, Routine fasting self-measured plasma glucose (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%., Baseline up to Week 24 | Other: Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24, 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., 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 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., Baseline, Week 24|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24, Change was calculated by subtracting baseline value from Week 24 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 the study drug or up to the introduction of rescue therapy, whichever is the earliest., 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
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| Locations: |
Sanofi-Aventis Investigational Site Number 840019, Montgomery, Alabama, 36109, United States|Sanofi-Aventis Investigational Site Number 840003, Muscle Shoals, Alabama, 35661, United States|Sanofi-Aventis Investigational Site Number 840022, Mesa, Arizona, 85206, United States|Sanofi-Aventis Investigational Site Number 840011, Anaheim, California, 92801, United States|Sanofi-Aventis Investigational Site Number 840014, Paramount, California, 90723, United States|Sanofi-Aventis Investigational Site Number 840027, Redlands, California, 92374, United States|Sanofi-Aventis Investigational Site Number 840021, Augusta, Georgia, 30909, United States|Sanofi-Aventis Investigational Site Number 840007, Roswell, Georgia, 30076, United States|Sanofi-Aventis Investigational Site Number 840016, Chicago, Illinois, 60610, United States|Sanofi-Aventis Investigational Site Number 840018, Chicago, Illinois, 60616, United States|Sanofi-Aventis Investigational Site Number 840001, Evansville, Indiana, 47714, United States|Sanofi-Aventis Investigational Site Number 840002, Baton Rouge, Louisiana, 70808, United States|Sanofi-Aventis Investigational Site Number 840031, Clarkston, Michigan, 48346, United States|Sanofi-Aventis Investigational Site Number 840020, Florissant, Missouri, 63031, United States|Sanofi-Aventis Investigational Site Number 840006, Butte, Montana, 59701, United States|Sanofi-Aventis Investigational Site Number 840026, Perrysburg, Ohio, 43551, United States|Sanofi-Aventis Investigational Site Number 840004, Medford, Oregon, 97504, United States|Sanofi-Aventis Investigational Site Number 840025, Altoona, Pennsylvania, 16602, United States|Sanofi-Aventis Investigational Site Number 840009, Brentwood, Tennessee, 37207, United States|Sanofi-Aventis Investigational Site Number 840008, Dallas, Texas, 75230, United States|Sanofi-Aventis Investigational Site Number 840010, San Antonio, Texas, 78229, United States|Sanofi-Aventis Investigational Site Number 036006, Adelaide, 5000, Australia|Sanofi-Aventis Investigational Site Number 036001, Box Hill, 3128, Australia|Sanofi-Aventis Investigational Site Number 036004, Elizabeth Vale, 5112, Australia|Sanofi-Aventis Investigational Site Number 036002, Geelong, 3220, Australia|Sanofi-Aventis Investigational Site Number 036005, Meadowbrook, 4131, Australia|Sanofi-Aventis Investigational Site Number 036003, Sydney, 2006, Australia|Sanofi-Aventis Investigational Site Number 076005, Belem, 66073-000, Brazil|Sanofi-Aventis Investigational Site Number 076001, Brasilia, 71625-009, Brazil|Sanofi-Aventis Investigational Site Number 076006, Caxias Do Sul, 95070-560, Brazil|Sanofi-Aventis Investigational Site Number 076003, Curitiba, 80060-900, Brazil|Sanofi-Aventis Investigational Site Number 076002, Rio De Janeiro, 20211-340, Brazil|Sanofi-Aventis Investigational Site Number 076004, Sao Paulo, 04024-002, Brazil|Sanofi-Aventis Investigational Site Number 076007, Sao Paulo, 05403-000, Brazil|Sanofi-Aventis Investigational Site Number 124004, Calgary, T2N 4N1, Canada|Sanofi-Aventis Investigational Site Number 124008, Hamilton, L8L 5G8, Canada|Sanofi-Aventis Investigational Site Number 124005, London, N6G 2M3, Canada|Sanofi-Aventis Investigational Site Number 124006, Montreal, H2W 1R7, Canada|Sanofi-Aventis Investigational Site Number 124013, Oakville, L6H 3P1, Canada|Sanofi-Aventis Investigational Site Number 124002, St-Romuald, G6W 5M6, Canada|Sanofi-Aventis Investigational Site Number 124012, Thornhill, L4J 8L7, Canada|Sanofi-Aventis Investigational Site Number 124011, Toronto, Canada|Sanofi-Aventis Investigational Site Number 124003, Vancouver, V5Z 1C6, Canada|Sanofi-Aventis Investigational Site Number 124007, Victoria, V8R 6V4, Canada|Sanofi-Aventis Investigational Site Number 152001, Santiago, 7500347, Chile|Sanofi-Aventis Investigational Site Number 152004, Santiago, 7500710, Chile|Sanofi-Aventis Investigational Site Number 152003, Santiago, 8053095, Chile|Sanofi-Aventis Investigational Site Number 152002, Santiago, Chile|Sanofi-Aventis Investigational Site Number 152005, Santiago, Chile|Sanofi-Aventis Investigational Site Number 276002, Berlin, 13125, Germany|Sanofi-Aventis Investigational Site Number 276005, Ludwigshafen, 67059, Germany|Sanofi-Aventis Investigational Site Number 276004, Schkeuditz, 04435, Germany|Sanofi-Aventis Investigational Site Number 320002, Guatemala, 01010, Guatemala|Sanofi-Aventis Investigational Site Number 320001, Guatemala, 01014, Guatemala|Sanofi-Aventis Investigational Site Number 320004, Guatemala, 1010, Guatemala|Sanofi-Aventis Investigational Site Number 320005, Guatemala, Guatemala|Sanofi-Aventis Investigational Site Number 320006, Guatemala, Guatemala|Sanofi-Aventis Investigational Site Number 484003, Aguascalientes, 20230, Mexico|Sanofi-Aventis Investigational Site Number 484010, Chihuahua, 31000, Mexico|Sanofi-Aventis Investigational Site Number 484009, Chihuahua, 31238, Mexico|Sanofi-Aventis Investigational Site Number 484012, Df, 03300, Mexico|Sanofi-Aventis Investigational Site Number 484008, Merida, 97000, Mexico|Sanofi-Aventis Investigational Site Number 484011, México City, 14050, Mexico|Sanofi-Aventis Investigational Site Number 484001, Pachuca, 42090, Mexico|Sanofi-Aventis Investigational Site Number 484005, Pachuca, 42090, Mexico|Sanofi-Aventis Investigational Site Number 484006, Veracruz, 91700, Mexico|Sanofi-Aventis Investigational Site Number 484002, Zapopan, 44030, Mexico|Sanofi-Aventis Investigational Site Number 604005, Lima, 27, Peru|Sanofi-Aventis Investigational Site Number 604003, Lima, Lima 27, Peru|Sanofi-Aventis Investigational Site Number 604001, Lima, Peru|Sanofi-Aventis Investigational Site Number 604002, Lima, Peru|Sanofi-Aventis Investigational Site Number 604004, Lima, Peru|Sanofi-Aventis Investigational Site Number 616002, Bialystok, 15-435, Poland|Sanofi-Aventis Investigational Site Number 616001, Bydgoszcz, 85-822, Poland|Sanofi-Aventis Investigational Site Number 616006, Warszawa, 02-507, Poland|Sanofi-Aventis Investigational Site Number 616003, Wroclaw, 50-127, Poland|Sanofi-Aventis Investigational Site Number 642004, Bacau, 600164, Romania|Sanofi-Aventis Investigational Site Number 642006, Bucuresti, 020475, Romania|Sanofi-Aventis Investigational Site Number 642008, Bucuresti, 022441, Romania|Sanofi-Aventis Investigational Site Number 642010, Iasi, 700515, Romania|Sanofi-Aventis Investigational Site Number 642009, Ploiesti, 100097, Romania|Sanofi-Aventis Investigational Site Number 642001, Resita, 320076, Romania|Sanofi-Aventis Investigational Site Number 642005, Suceava, 720262, Romania|Sanofi-Aventis Investigational Site Number 642007, Timisoara, 300593, Romania|Sanofi-Aventis Investigational Site Number 643002, Kazan, 420012, Russian Federation|Sanofi-Aventis Investigational Site Number 643003, St-Petersburg, 195257, Russian Federation|Sanofi-Aventis Investigational Site Number 643005, St-Petersburg, 198013, Russian Federation|Sanofi-Aventis Investigational Site Number 643001, St. Petersburg, 194358, Russian Federation|Sanofi-Aventis Investigational Site Number 643004, Tyumen, 625023, Russian Federation|Sanofi-Aventis Investigational Site Number 804003, Chernivtsi, 58022, Ukraine|Sanofi-Aventis Investigational Site Number 804001, Kiev, 2091, Ukraine|Sanofi-Aventis Investigational Site Number 804004, Kyiv, 31156, Ukraine
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