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Clinical Trial Details

Trial ID: L4639
Source ID: NCT03529123
Associated Drug: Insulin Glargine/Lixisenatide (Hoe901/Ave0010)
Title: Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)|DRUG: INSULIN GLARGINE (HOE901)|DRUG: Metformin|DRUG: Insulin Glulisine (HMR1964)
Outcome Measures: Primary: Change in HbA1c, Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24, From baseline to Week 24 | Secondary: Patients with HbA1c <7%, Number of patients reaching HbA1c \<7 % at the end of Week 24, At Week 24|Change in 2-hour Post prandial glucose (PPG), Change in 2-hour PPG from baseline to Week 24, From baseline to Week 24|Change in body weight, Change in body weight from baseline to Week 24, From baseline to Week 24|Patients with HbA1c <7% with no body weight gain and no hypoglycemia, Number of patients reaching HbA1c \<7% with no body weight gain and no hypoglycemia at the end of Week 24, At Week 24|Change in Fasting Plasma Glucose, Mean change in FPG from baseline to Week 24, From baseline to Week 24|Adverse events (AE), Number of AEs, Up to 33 weeks|Patients with HbA1c <7% with no body weight gain, Number of patients reaching HbA1c \<7% with no body weight gain at the end of Week 24, At Week 24|Change in SMPG profiles, Change in 7-point self-monitoring plasma glucose (SMPG) profiles from baseline to Week 24, From baseline to Week 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 247
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-06-19
Completion Date: 2019-11-25
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 01, Bangalore, 560092, India|Investigational Site Number 012, Belgaum, 590010, India|Investigational Site Number 013, Chennai, 600086, India|Investigational Site Number 017, Coimbatore, 641009, India|Investigational Site Number 06, Hyderabad, 500063, India|Investigational Site Number 07, Hyderabad, 500072, India|Investigational Site Number 08, Jaipur, India|Investigational Site Number 04, Kolkata, 700107, India|Investigational Site Number 018, Lucknow, India|Investigational Site Number 014, Madurai, 625020, India|Investigational Site Number 05, Nasik, 422002, India|Investigational Site Number 010, New Delhi, 110029, India|Investigational Site Number 016, Pune, 411040, India
URL: https://clinicaltrials.gov/show/NCT03529123