| 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 the time from the first dose of study drug up to 14 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 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 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 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 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 24|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile 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 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 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. 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 Insulin Glargine Daily Dose at Week 24, Change was calculated 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. 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 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 24|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 14 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 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 14 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 24|Percentage of Patients Requiring Rescue Therapy During the Double-blind Period, Routine fasting SMPG, central laboratory FPG and HbA1c 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 were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c \>9%, from Week 8 to Week 24: fasting SMPG/FPG \>180 mg/dL (10.0 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|Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24, Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. 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 24 | Other: 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. 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
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| Locations: |
Sanofi-Aventis Investigational Site Number 840223, Mesa, Arizona, 85206, United States|Sanofi-Aventis Investigational Site Number 840206, Hot Springs, Arkansas, 71913, United States|Sanofi-Aventis Investigational Site Number 840201, Little Rock, Arkansas, 72205, United States|Sanofi-Aventis Investigational Site Number 840212, Mountain Home, Arkansas, 72653, United States|Sanofi-Aventis Investigational Site Number 840215, Concord, California, 94520, United States|Sanofi-Aventis Investigational Site Number 840214, Greenbrae, California, 94904, United States|Sanofi-Aventis Investigational Site Number 840221, Orlando, Florida, 32835, United States|Sanofi-Aventis Investigational Site Number 840211, Baton Rouge, Louisiana, 70808, United States|Sanofi-Aventis Investigational Site Number 840230, Hyattsville, Maryland, 20781, United States|Sanofi-Aventis Investigational Site Number 840209, Rockville, Maryland, 20852, United States|Sanofi-Aventis Investigational Site Number 840219, Brighton, Michigan, 48114, United States|Sanofi-Aventis Investigational Site Number 840231, Sea Girt, New Jersey, 08750, United States|Sanofi-Aventis Investigational Site Number 840208, Fargo, North Dakota, 58103, United States|Sanofi-Aventis Investigational Site Number 840225, Mentor, Ohio, 44060, United States|Sanofi-Aventis Investigational Site Number 840222, Portland, Oregon, 97201-3098, United States|Sanofi-Aventis Investigational Site Number 840202, Philadelphia, Pennsylvania, 19146, United States|Sanofi-Aventis Investigational Site Number 840229, Bristol, Tennessee, 37620, United States|Sanofi-Aventis Investigational Site Number 840205, Germantown, Tennessee, 38138, United States|Sanofi-Aventis Investigational Site Number 840210, Dallas, Texas, 75230, United States|Sanofi-Aventis Investigational Site Number 840217, Houston, Texas, 77081, United States|Sanofi-Aventis Investigational Site Number 840228, Houston, Texas, 77081, United States|Sanofi-Aventis Investigational Site Number 840213, Plano, Texas, 75093, United States|Sanofi-Aventis Investigational Site Number 840227, Norfolk, Virginia, 23502, United States|Sanofi-Aventis Investigational Site Number 032204, Buenos Aires, Argentina|Sanofi-Aventis Investigational Site Number 032205, Capital Federal, 1012, Argentina|Sanofi-Aventis Investigational Site Number 032201, Capital Federal, 1425, Argentina|Sanofi-Aventis Investigational Site Number 032209, Capital Federal, C1056ABJ, Argentina|Sanofi-Aventis Investigational Site Number 032211, Corrientes, Argentina|Sanofi-Aventis Investigational Site Number 032202, Parana, (E3100BBJ), Argentina|Sanofi-Aventis Investigational Site Number 032203, Rosario, 2000, Argentina|Sanofi-Aventis Investigational Site Number 076207, Belem, 66073-000, Brazil|Sanofi-Aventis Investigational Site Number 076202, Brasilia, 71625-009, Brazil|Sanofi-Aventis Investigational Site Number 076205, Porto Alegre, 90035001, Brazil|Sanofi-Aventis Investigational Site Number 076204, Sao Paulo, 04024-002, Brazil|Sanofi-Aventis Investigational Site Number 124219, Brampton, L6R 3J5, Canada|Sanofi-Aventis Investigational Site Number 124213, Chatham, N7L 1C1, Canada|Sanofi-Aventis Investigational Site Number 124208, Chilliwack, V2P 4M9, Canada|Sanofi-Aventis Investigational Site Number 124215, Etobicoke, M9R 4E1, Canada|Sanofi-Aventis Investigational Site Number 124205, Quebec, G1V 4G5, Canada|Sanofi-Aventis Investigational Site Number 124202, Red Deer, T4N 6V7, Canada|Sanofi-Aventis Investigational Site Number 124218, Thornhill, L4J 8L7, Canada|Sanofi-Aventis Investigational Site Number 124201, Toronto, M4R 2G4, Canada|Sanofi-Aventis Investigational Site Number 124207, Toronto, M9V 4B4, Canada|Sanofi-Aventis Investigational Site Number 124209, Victoria, V8V 4A1, Canada|Sanofi-Aventis Investigational Site Number 124217, Winnipeg, R3E 3P4, Canada|Sanofi-Aventis Investigational Site Number 152202, Santiago, 7500010, Chile|Sanofi-Aventis Investigational Site Number 152203, Santiago, 7980378, Chile|Sanofi-Aventis Investigational Site Number 152206, Santiago, 8053095, Chile|Sanofi-Aventis Investigational Site Number 152204, Santiago, 8360156, Chile|Sanofi-Aventis Investigational Site Number 152205, Santiago, 8930211, Chile|Sanofi-Aventis Investigational Site Number 152201, Santiago, Chile|Sanofi-Aventis Investigational Site Number 170204, Barranquilla, Colombia|Sanofi-Aventis Investigational Site Number 170201, Bogota, Colombia|Sanofi-Aventis Investigational Site Number 170202, Bogota, Colombia|Sanofi-Aventis Investigational Site Number 203202, Hradec Kralove, 50005, Czech Republic|Sanofi-Aventis Investigational Site Number 203204, Praha 5, 15006, Czech Republic|Sanofi-Aventis Investigational Site Number 208202, Frederiksberg, 2000, Denmark|Sanofi-Aventis Investigational Site Number 208201, København Nv, 2400, Denmark|Sanofi-Aventis Investigational Site Number 208205, Slagelse, 4200, Denmark|Sanofi-Aventis Investigational Site Number 233201, Pärnu, 80018, Estonia|Sanofi-Aventis Investigational Site Number 233203, Tallinn, 13415, Estonia|Sanofi-Aventis Investigational Site Number 233204, Tartu, 50410, Estonia|Sanofi-Aventis Investigational Site Number 233202, Viljandimaa, 71024, Estonia|Sanofi-Aventis Investigational Site Number 250204, Amiens Cedex 1, 80054, France|Sanofi-Aventis Investigational Site Number 250206, La Rochelle Cedex, 17019, France|Sanofi-Aventis Investigational Site Number 250203, Le Creusot, 71200, France|Sanofi-Aventis Investigational Site Number 250201, Nantes, 44093, France|Sanofi-Aventis Investigational Site Number 250202, Pierre Benite, 69310, France|Sanofi-Aventis Investigational Site Number 276201, Dresden, 01307, Germany|Sanofi-Aventis Investigational Site Number 276202, Mainz, 55116, Germany|Sanofi-Aventis Investigational Site Number 276204, St. Ingbert-Oberwürzbach, 66386, Germany|Sanofi-Aventis Investigational Site Number 348205, Balatonfüred, 8230, Hungary|Sanofi-Aventis Investigational Site Number 348202, Budapest, 1036, Hungary|Sanofi-Aventis Investigational Site Number 348207, Budapest, Hungary|Sanofi-Aventis Investigational Site Number 348204, Debrecen, 4031, Hungary|Sanofi-Aventis Investigational Site Number 348206, Gyula, 5700, Hungary|Sanofi-Aventis Investigational Site Number 348203, Szeged, 6722, Hungary|Sanofi-Aventis Investigational Site Number 348201, Zalaegerszeg, 8900, Hungary|Sanofi-Aventis Investigational Site Number 356210, Ahmedabad, 380015, India|Sanofi-Aventis Investigational Site Number 356206, Bangalore, 560043, India|Sanofi-Aventis Investigational Site Number 356204, Bangalore, 560052, India|Sanofi-Aventis Investigational Site Number 356202, Bangalore, India|Sanofi-Aventis Investigational Site Number 356201, Belgaum, 590001, India|Sanofi-Aventis Investigational Site Number 356205, Chennai, 600086, India|Sanofi-Aventis Investigational Site Number 356208, Indore, 452010, India|Sanofi-Aventis Investigational Site Number 356203, Karnal, 132001, India|Sanofi-Aventis Investigational Site Number 356207, Kochi, India|Sanofi-Aventis Investigational Site Number 356209, Nagpur, 440012, India|Sanofi-Aventis Investigational Site Number 376202, Haifa, 31096, Israel|Sanofi-Aventis Investigational Site Number 376201, Holon, 58100, Israel|Sanofi-Aventis Investigational Site Number 376204, Kfar Saba, 44281, Israel|Sanofi-Aventis Investigational Site Number 376203, Tel Hashomer, 52621, Israel|Sanofi-Aventis Investigational Site Number 380201, Milano, 20132, Italy|Sanofi-Aventis Investigational Site Number 380202, Perugia, 61260, Italy|Sanofi-Aventis Investigational Site Number 458203, Kelantan, 16150, Malaysia|Sanofi-Aventis Investigational Site Number 458202, Kuala Lumpur, 56000, Malaysia|Sanofi-Aventis Investigational Site Number 484201, Cuernavaca, 62250, Mexico|Sanofi-Aventis Investigational Site Number 484204, Durango, 34270, Mexico|Sanofi-Aventis Investigational Site Number 484203, Guadalajara, 44600, Mexico|Sanofi-Aventis Investigational Site Number 484206, México City, 14050, Mexico|Sanofi-Aventis Investigational Site Number 484205, Tlalnepantla, 53160, Mexico|Sanofi-Aventis Investigational Site Number 528203, Amsterdam, 1066 EC, Netherlands|Sanofi-Aventis Investigational Site Number 528202, Groningen, 9728 NT, Netherlands|Sanofi-Aventis Investigational Site Number 528204, Zwijndrecht, 3331 LZ, Netherlands|Sanofi-Aventis Investigational Site Number 616202, Krakow, 31-548, Poland|Sanofi-Aventis Investigational Site Number 616208, Lubin, 59-300, Poland|Sanofi-Aventis Investigational Site Number 616206, Plock, 09-400, Poland|Sanofi-Aventis Investigational Site Number 616207, Pulawy, 24-100, Poland|Sanofi-Aventis Investigational Site Number 616205, Sopot, 81-756, Poland|Sanofi-Aventis Investigational Site Number 616201, Szczecin, 70-506, Poland|Sanofi-Aventis Investigational Site Number 616203, Zabrze, 41-8--, Poland|Sanofi-Aventis Investigational Site Number 840226, Ponce, 00717, Puerto Rico|Sanofi-Aventis Investigational Site Number 840216, San Juan, 00917, Puerto Rico|Sanofi-Aventis Investigational Site Number 642204, Brasov, 500326, Romania|Sanofi-Aventis Investigational Site Number 642208, Bucharest, 020725, Romania|Sanofi-Aventis Investigational Site Number 642205, Deva, 330084, Romania|Sanofi-Aventis Investigational Site Number 642203, Iasi, 700515, Romania|Sanofi-Aventis Investigational Site Number 642202, Oradea, 410598, Romania|Sanofi-Aventis Investigational Site Number 642206, Targu Mures, 540061, Romania|Sanofi-Aventis Investigational Site Number 642207, Timisoara, 300456, Romania|Sanofi-Aventis Investigational Site Number 642201, Timisoara, 300593, Romania|Sanofi-Aventis Investigational Site Number 643203, Saratov, 410030, Russian Federation|Sanofi-Aventis Investigational Site Number 643202, St. Petersburg, 194358, Russian Federation|Sanofi-Aventis Investigational Site Number 710202, Cape Town, 7708, South Africa|Sanofi-Aventis Investigational Site Number 710201, Durban, 4092, South Africa|Sanofi-Aventis Investigational Site Number 710203, Pretoria, South Africa|Sanofi-Aventis Investigational Site Number 752204, Göteborg, 413 45, Sweden|Sanofi-Aventis Investigational Site Number 752203, Härnösand, 871 82, Sweden|Sanofi-Aventis Investigational Site Number 752205, Luleå, 972 33, Sweden|Sanofi-Aventis Investigational Site Number 752202, Malmö, 211 52, Sweden|Sanofi-Aventis Investigational Site Number 752201, Stockholm, 111 57, Sweden|Sanofi-Aventis Investigational Site Number 158204, Changhua, 500, Taiwan|Sanofi-Aventis Investigational Site Number 158201, Taichung R.O.C., 407, Taiwan|Sanofi-Aventis Investigational Site Number 158203, Taichung, 433, Taiwan|Sanofi-Aventis Investigational Site Number 158202, Tainan Hsien, 710, Taiwan|Sanofi-Aventis Investigational Site Number 804203, Chernivtsi, 58022, Ukraine|Sanofi-Aventis Investigational Site Number 804201, Kiev, 2091, Ukraine|Sanofi-Aventis Investigational Site Number 804205, Kyiv, 31156, Ukraine|Sanofi-Aventis Investigational Site Number 804202, Kyiv, Ukraine|Sanofi-Aventis Investigational Site Number 804204, Vinnytsya, 21010, Ukraine
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