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Clinical Trial Details

Trial ID: L5313
Source ID: NCT02545842
Associated Drug: Insulin Glargine
Title: Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: INSULIN GLARGINE
Outcome Measures: Primary: Percentage of patients with HbA1c <7% achievement, 24 weeks | Secondary: Percentage of patients achieving HbA1c <=6.5%, 24 weeks|Percentage of patients achieving FPG target with HbA1c <7%, 24 weeks|Percentage of patients achieving HbA1c <7% without hypoglycemia, 24 weeks|Percentage of patients achieving the FPG target without hypoglycemia, 24 weeks|Percentage of patients achieving FPG target, 24 weeks|Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L), 24 weeks|Change from baseline in HbA1c, Baseline to 24 weeks|Change in FPG, 8 weeks to 24 weeks|Change in PPG, Baseline to 24 weeks|Change in insulin doses in each arm, 1 week to 24 weeks|Change in body weight in each treatment arm, Baseline to 24 weeks|Percentage of patients experienced hypoglycemic events, 24 weeks
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 947
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-09-07
Completion Date: 2018-04-20
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 156053, Anshan, China|Investigational Site Number 156001, Beijing, China|Investigational Site Number 156002, Beijing, China|Investigational Site Number 156006, Beijing, China|Investigational Site Number 156013, Changchun, 130033, China|Investigational Site Number 156014, Changchun, 130033, China|Investigational Site Number 156022, Changde, 415000, China|Investigational Site Number 156017, Changsha, China|Investigational Site Number 156034, Changzhou, China|Investigational Site Number 156023, Chenzhou, China|Investigational Site Number 156026, Guangzhou, 510515, China|Investigational Site Number 156029, Haikou, 570102, China|Investigational Site Number 156028, Haikou, China|Investigational Site Number 156040, Haikou, China|Investigational Site Number 156039, Hangzhou, 310013, China|Investigational Site Number 156038, Hangzhou, China|Investigational Site Number 156042, Hangzhou, China|Investigational Site Number 156044, Hangzhou, China|Investigational Site Number 156048, Hefei, China|Investigational Site Number 156050, Hefei, China|Investigational Site Number 156011, Kunming, China|Investigational Site Number 156052, Kunming, China|Investigational Site Number 156016, Lanzhou, China|Investigational Site Number 156041, Lishui, China|Investigational Site Number 156020, Nanchang, 330006, China|Investigational Site Number 156018, Nanchang, China|Investigational Site Number 156019, Nanchang, China|Investigational Site Number 156031, Nanjing, China|Investigational Site Number 156043, Nanjing, China|Investigational Site Number 156049, Nanjing, China|Investigational Site Number 156035, Shanghai, China|Investigational Site Number 156036, Shanghai, China|Investigational Site Number 156047, Shanghai, China|Investigational Site Number 156027, Shantou, China|Investigational Site Number 156015, Shenyang, China|Investigational Site Number 156054, Shijiazhuang, China|Investigational Site Number 156007, Tangshan, 063000, China|Investigational Site Number 156010, Tianjin, 300032, China|Investigational Site Number 156055, Wuhan, 430000, China|Investigational Site Number 156037, Xuzhou, China|Investigational Site Number 156033, Yangzhou, China|Investigational Site Number 156030, Yueyang, China|Investigational Site Number 156032, Zhenjiang, 212001, China|Investigational Site Number 156025, Zhuzhou, 412000, China
URL: https://clinicaltrials.gov/show/NCT02545842

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