| 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 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 on-treatment assessment for at least 1 efficacy variable, were required., Baseline, Week 24 | Secondary: 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 on-treatment assessment for at least 1 efficacy variable, were required., 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 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. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment 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 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 on-treatment 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 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 on-treatment assessment for at least 1 efficacy variable, were required., 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., Baseline, Week 24|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period, Routine fasting self-monitored 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 \>250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \>220 mg/dL (12.2 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 on-treatment assessment for at least 1 efficacy variable, were required., Baseline up to 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 on-treatment 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: |
Investigational Site Number 156011, Beijing, 100034, China|Investigational Site Number 156012, Beijing, 100101, China|Investigational Site Number 156019, Beijing, 100191, China|Investigational Site Number 156002, Beijing, 100700, China|Investigational Site Number 156003, Beijing, 100730, China|Investigational Site Number 156009, Beijing, 100730, China|Investigational Site Number 156001, Beijing, 100853, China|Investigational Site Number 156036, Changchun, 130041, China|Investigational Site Number 156016, Changsha, 410008, China|Investigational Site Number 156015, Changsha, 410011, China|Investigational Site Number 156006, Chengdu, 610041, China|Investigational Site Number 156032, Chengdu, 610072, China|Investigational Site Number 156010, Dalian, 116027, China|Investigational Site Number 156004, Guangzhou, 510080, China|Investigational Site Number 156008, Guangzhou, 510080, China|Investigational Site Number 156025, Guangzhou, 510630, China|Investigational Site Number 156031, Haikou, 57028, China|Investigational Site Number 156014, Harbin, 150001, China|Investigational Site Number 156029, Hefei, 230022, China|Investigational Site Number 156013, Qingdao, 266003, China|Investigational Site Number 156007, Shanghai, 200003, China|Investigational Site Number 156030, Shanghai, 200065, China|Investigational Site Number 156020, Shenyang, 110004, China|Investigational Site Number 156035, Suzhou, 215004, China|Investigational Site Number 156033, Taiyuan, 030001, China|Investigational Site Number 156037, Tianjin, 300052, China|Investigational Site Number 156022, Xi'An, 710032, China|Investigational Site Number 156023, Xi'An, 710061, China|Investigational Site Number 344001, Hong Kong, Hong Kong|Investigational Site Number 344003, Hong Kong, Hong Kong|Investigational Site Number 344002, Shatin, Nt, Hong Kong|Investigational Site Number 458001, Kelantan, 16150, Malaysia|Investigational Site Number 458003, Kuala Lumpur, 59100, Malaysia|Investigational Site Number 458002, Putrajaya, 62250, Malaysia|Investigational Site Number 764002, Bangkok, 10400, Thailand
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