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Clinical Trial Details

Trial ID: L5087
Source ID: NCT02749890
Associated Drug: Insulin Glargine/Lixisenatide (Hoe901/Ave0010)
Title: Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
Acronym: LIXILAN JP-O1
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glargine/Lixisenatide (HOE901/AVE0010)|DRUG: Lixisenatide (AVE0010)|DRUG: Oral anti-diabetic drugs
Outcome Measures: Primary: Change from baseline in HbA1c, Baseline, 26 weeks | Secondary: Percentage of patients reaching HbA1c <7% or ≤6.5%, 26 weeks|Change from baseline in fasting plasma glucose, Baseline, 26 weeks|Change in from baseline in 7 point self-monitored plasma profiles, Baseline, 26 weeks|Percentage of patients reaching HbA1c <7% with no body weight gain, 26 weeks|Change from baseline in body weight, Baseline, 26 weeks|Percentage of patients requiring a rescue therapy, 26 weeks|Change in daily dose of insulin glargine for the combination group, Day 1, 26 weeks|Number of hypoglycemic events, 26 weeks, 52 weeks|Number of adverse events, 26 weeks, 52 weeks|Measurement of anti-lixisenatide antibodies from baseline, Baseline, 26 weeks, 52 weeks|Measurement of anti-insulin antibodies from baseline, Baseline, 26 weeks, 52 weeks
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 321
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-05-09
Completion Date: 2018-05
Results First Posted:
Last Update Posted: 2020-06-16
Locations: Investigational Site Number 392002, Adachi-Ku, Japan|Investigational Site Number 392009, Arakawa-Ku, Japan|Investigational Site Number 392025, Atsugi-Shi, Japan|Investigational Site Number 392060, Bunkyo-Ku, Japan|Investigational Site Number 392024, Chiba-Shi, Japan|Investigational Site Number 392011, Chigasaki-Shi, Japan|Investigational Site Number 392013, Chiyoda-Ku, Japan|Investigational Site Number 392052, Chiyoda-Ku, Japan|Investigational Site Number 392003, Chuo-Ku, Japan|Investigational Site Number 392017, Chuo-Ku, Japan|Investigational Site Number 392008, Fujimi-Shi, Japan|Investigational Site Number 392054, Fukuoka-Shi, Japan|Investigational Site Number 392094, Fukuoka-Shi, Japan|Investigational Site Number 392059, Hachioji-Shi, Japan|Investigational Site Number 392083, Hakodate-Shi, Japan|Investigational Site Number 392048, Hamamatsu-Shi, Japan|Investigational Site Number 392079, Hiki-Gun, Japan|Investigational Site Number 392057, Iruma-Shi, Japan|Investigational Site Number 392022, Ise-Shi, Japan|Investigational Site Number 392023, Isehara-Shi, Japan|Investigational Site Number 392020, Izumisano-Shi, Japan|Investigational Site Number 392066, Kashiwa-Shi, Japan|Investigational Site Number 392006, Kasugai-Shi, Japan|Investigational Site Number 392053, Kawagoe-Shi, Japan|Investigational Site Number 392065, Kawagoe-Shi, Japan|Investigational Site Number 392007, Kawaguchi-Shi, Japan|Investigational Site Number 392062, Kawaguchi-Shi, Japan|Investigational Site Number 392077, Kawasaki-Shi, Japan|Investigational Site Number 392082, Kawasaki-Shi, Japan|Investigational Site Number 392031, Kitakyushu-Shi, Japan|Investigational Site Number 392041, Kitakyusyu-Shi, Japan|Investigational Site Number 392068, Kitakyusyu-Shi, Japan|Investigational Site Number 392044, Koga-Shi, Japan|Investigational Site Number 392001, Koriyama-Shi, Japan|Investigational Site Number 392032, Kurume-Shi, Japan|Investigational Site Number 392088, Maebashi-Shi, Japan|Investigational Site Number 392014, Mitaka-Shi, Japan|Investigational Site Number 392042, Mito-Shi, Japan|Investigational Site Number 392078, Mito-Shi, Japan|Investigational Site Number 392026, Nagoya-Shi, Japan|Investigational Site Number 392080, Okayama-Shi, Japan|Investigational Site Number 392040, Oyama-Shi, Japan|Investigational Site Number 392038, Sagamihara-Shi, Japan|Investigational Site Number 392069, Saijo-Shi, Japan|Investigational Site Number 392030, Saitama-Shi, Japan|Investigational Site Number 392047, Sapporo-Shi, Japan|Investigational Site Number 392015, Satsumasendai-Shi, Japan|Investigational Site Number 392004, Sendai-Shi, Japan|Investigational Site Number 392034, Shimotsuke-Shi, Japan|Investigational Site Number 392037, Shizuoka-Shi, Japan|Investigational Site Number 392081, Shizuoka-Shi, Japan|Investigational Site Number 392019, Shobara-Shi, Japan|Investigational Site Number 392018, Shunan-Shi, Japan|Investigational Site Number 392027, Suita-Shi, Japan|Investigational Site Number 392056, Taito-Ku, Japan|Investigational Site Number 392051, Takatsuki-Shi, Japan|Investigational Site Number 392061, Tokorozawa-Shi, Japan|Investigational Site Number 392029, Toyonaka-Shi, Japan|Investigational Site Number 392093, Ube-Shi, Japan|Investigational Site Number 392067, Yatsushiro-Shi, Japan|Investigational Site Number 392035, Zentsuji-Shi, Japan
URL: https://clinicaltrials.gov/show/NCT02749890

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