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Clinical Trial Details

Trial ID: L5960
Source ID: NCT01632163
Associated Drug: Lixisenatide (Ave0010)
Title: Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Lixisenatide (AVE0010)|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c, from baseline to week 24 | Secondary: Percentage of patients with HbA1c <7%, =<6.5%, at week 24|Change in 2-hour postprandial plasma glucose and plasma glucose excursion, from baseline to week 24|Change in fasting plasma glucose, from baseline to week 24|Change in 7-point self monitoring plasma glucose profile (average and each point), from baseline to week 24|Change in body weight, from baseline to week 24|Change in daily basal insulin dose, from baseline to week 24|Number of patients with adverse events, 24 weeks|Anti-lixisenatide antibody assessment, from baseline to week 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 447
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-10
Completion Date: 2015-05
Results First Posted:
Last Update Posted: 2015-06-15
Locations: Investigational Site Number 156001, Beijing, 100029, China|Investigational Site Number 156033, Beijing, 100034, China|Investigational Site Number 156006, Beijing, 100088, China|Investigational Site Number 156005, Beijing, 100700, China|Investigational Site Number 156004, Beijing, 100730, China|Investigational Site Number 156002, Beijing, 100853, China|Investigational Site Number 156016, Changchun, 130041, China|Investigational Site Number 156025, Changsha, 410011, China|Investigational Site Number 156014, Chengdu, 610041, China|Investigational Site Number 156013, Chengdu, 610072, China|Investigational Site Number 156034, Dalian, 116027, China|Investigational Site Number 156035, Fuzhou, 354200, China|Investigational Site Number 156021, Guangzhou, 510515, China|Investigational Site Number 156023, Haikou, 570311, China|Investigational Site Number 156017, Harbin, 150001, China|Investigational Site Number 156026, Jinan, 250012, China|Investigational Site Number 156029, Jinan, 250013, China|Investigational Site Number 156019, Nanjing, 210008, China|Investigational Site Number 156020, Nanjing, 210011, China|Investigational Site Number 156018, Qingdao, 266003, China|Investigational Site Number 156028, Shanghai, 200003, China|Investigational Site Number 156007, Shanghai, 200072, China|Investigational Site Number 156032, Shenyang, 110022, China|Investigational Site Number 156009, Shijiazhuang, 050051, China|Investigational Site Number 156036, Siping, 136000, China|Investigational Site Number 156010, Suzhou, 215004, China|Investigational Site Number 156008, Tianjin, 300052, China|Investigational Site Number 156027, Wuhan, 430030, China|Investigational Site Number 156011, Xi'An, 710032, China|Investigational Site Number 156012, Xi'An, 710061, China|Investigational Site Number 356019, Ahmedabad, 380008, India|Investigational Site Number 356018, Aligarh, 202 002, India|Investigational Site Number 356026, Bangalore, 560092, India|Investigational Site Number 356017, Bhubaneswar, 751005, India|Investigational Site Number 356002, Hyderabad, 500004, India|Investigational Site Number 356024, Hyderabad, 500063, India|Investigational Site Number 356015, Nagpur, 440012, India|Investigational Site Number 356008, Pune, 411001, India|Investigational Site Number 356021, Secunderabad, 500003, India|Investigational Site Number 356023, Visakhapatnam, 530002, India|Investigational Site Number 410003, Daegu, 705-703, Korea, Republic of|Investigational Site Number 410007, Goyang, 411-706, Korea, Republic of|Investigational Site Number 410006, Seoul, 130-872, Korea, Republic of|Investigational Site Number 410001, Seoul, 136-705, Korea, Republic of|Investigational Site Number 410005, Seoul, 139-872, Korea, Republic of|Investigational Site Number 410002, Wonju, 220-701, Korea, Republic of|Investigational Site Number 643007, Kirov, 610014, Russian Federation|Investigational Site Number 643006, Samara, 443067, Russian Federation|Investigational Site Number 643003, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643004, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643005, St-Petersburg, 195112, Russian Federation
URL: https://clinicaltrials.gov/show/NCT01632163

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