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Clinical Trial Details

Trial ID: L2557
Source ID: NCT02752412
Associated Drug: Insulin Glargine/Lixisenatide (Hoe901/Ave0010)
Title: Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs
Acronym: LIXILAN JP-L
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glargine/Lixisenatide (HOE901/AVE0010)|DRUG: Insulin glargine U100 (HOE901)|DRUG: Metformin
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 2-hour postprandial plasma glucose (PPG) during standardized meal test, Baseline, 26 weeks|Change from baseline in blood glucose excursion during standardized meal test, Baseline, 26 weeks|Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value), Baseline, 26 weeks|Change from baseline in body weight, Baseline, 26 weeks|Change from baseline in FPG, Baseline, 26 weeks|Change from baseline in daily dose of insulin glargine, Baseline, 26 weeks|Percentage of patients reaching HbA1c <7% with no body weight gain, 26 weeks|Percentage of patients reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia, 26 weeks|Percentage of patients reaching HbA1c <7% with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia, 26 weeks|Percentage of patients requiring a rescue therapy, 26 weeks|Number of hypoglycemic events, 26 weeks|Number of adverse events, 26 weeks|Measurement of anti-lixisenatide antibodies from baseline, Baseline, 26 weeks|Measurement of anti-insulin antibodies from baseline, Baseline, 26 weeks
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 513
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-05-17
Completion Date: 2018-10-04
Results First Posted:
Last Update Posted: 2020-06-16
Locations: Investigational Site Number 392002, Adachi-Ku, Japan|Investigational Site Number 392132, Annaka-Shi, Japan|Investigational Site Number 392009, Arakawa-Ku, Japan|Investigational Site Number 392152, Asahikawa-Shi, Japan|Investigational Site Number 392025, Atsugi-Shi, Japan|Investigational Site Number 392024, Chiba-Shi, Japan|Investigational Site Number 392151, 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 392055, Chuo-Ku, Japan|Investigational Site Number 392008, Fujimi-Shi, Japan|Investigational Site Number 392143, Fujisawa-Shi, Japan|Investigational Site Number 392094, Fukuoka-Shi, Japan|Investigational Site Number 392147, Fukuoka-Shi, Japan|Investigational Site Number 392100, Gifu-Shi, Japan|Investigational Site Number 392059, Hachioji-Shi, Japan|Investigational Site Number 392048, Hamamatsu-Shi, Japan|Investigational Site Number 392102, Hamamatsu-Shi, Japan|Investigational Site Number 392123, Higashiosaka-Shi, Japan|Investigational Site Number 392135, Higashiosaka-Shi, Japan|Investigational Site Number 392079, Hiki-Gun, Japan|Investigational Site Number 392141, Himeji-Shi, Japan|Investigational Site Number 392057, Iruma-Shi, Japan|Investigational Site Number 392022, Ise-Shi, Japan|Investigational Site Number 392020, Izumisano-Shi, Japan|Investigational Site Number 392036, Kamakura-Shi, Japan|Investigational Site Number 392136, Kamogawa-Shi, Japan|Investigational Site Number 392066, Kashiwa-Shi, Japan|Investigational Site Number 392045, Kashiwara-Shi, Japan|Investigational Site Number 392006, Kasugai-Shi, Japan|Investigational Site Number 392149, 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 392090, Kawaguchi-Shi, Japan|Investigational Site Number 392077, Kawasaki-Shi, Japan|Investigational Site Number 392082, Kawasaki-Shi, Japan|Investigational Site Number 392142, Kawasaki-Shi, Japan|Investigational Site Number 392010, Kisarazu-Shi, Japan|Investigational Site Number 392016, Kisarazu-Shi, Japan|Investigational Site Number 392031, Kitakyushu-Shi, Japan|Investigational Site Number 392068, Kitakyushu-Shi, Japan|Investigational Site Number 392041, Kitakyusyu-Shi, Japan|Investigational Site Number 392086, Kobe-Shi, Japan|Investigational Site Number 392044, Koga-Shi, Japan|Investigational Site Number 392001, Koriyama-Shi, Japan|Investigational Site Number 392028, Kumamoto-Shi, Japan|Investigational Site Number 392092, Kumamoto-Shi, Japan|Investigational Site Number 392108, Kumamoto-Shi, Japan|Investigational Site Number 392116, Kumamoto-Shi, Japan|Investigational Site Number 392099, Kushiro-Shi, Japan|Investigational Site Number 392049, Kyoto-Shi, Japan|Investigational Site Number 392107, Kyoto-Shi, Japan|Investigational Site Number 392088, Maebashi-Shi, Japan|Investigational Site Number 392158, Maebashi-Shi, Japan|Investigational Site Number 392121, Matsuyama-Shi, Japan|Investigational Site Number 392122, Minato-Ku, Japan|Investigational Site Number 392076, Misato-Shi, Japan|Investigational Site Number 392014, Mitaka-Shi, Japan|Investigational Site Number 392042, Mito-Shi, Japan|Investigational Site Number 392043, Mito-Shi, Japan|Investigational Site Number 392078, Mito-Shi, Japan|Investigational Site Number 392046, Miyazaki-Shi, Japan|Investigational Site Number 392026, Nagoya-Shi, Japan|Investigational Site Number 392101, Nagoya-Shi, Japan|Investigational Site Number 392128, Nagoya-Shi, Japan|Investigational Site Number 392131, Nagoya-Shi, Japan|Investigational Site Number 392134, Nagoya-Shi, Japan|Investigational Site Number 392137, Nagoya-Shi, Japan|Investigational Site Number 392140, Nagoya-Shi, Japan|Investigational Site Number 392154, Naka-Shi, Japan|Investigational Site Number 392050, Niihama-Shi, Japan|Investigational Site Number 392159, Obihiro-Shi, Japan|Investigational Site Number 392145, Ogaki-Shi, Japan|Investigational Site Number 392153, Oita-Shi, Japan|Investigational Site Number 392005, Okawa-Shi, Japan|Investigational Site Number 392071, Okayama-Shi, Japan|Investigational Site Number 392080, Okayama-Shi, Japan|Investigational Site Number 392095, Onga-Gun, Japan|Investigational Site Number 392105, Osaka-Shi, Japan|Investigational Site Number 392117, Osaka-Shi, Japan|Investigational Site Number 392144, Osaka-Shi, Japan|Investigational Site Number 392125, Osaki-Shi, Japan|Investigational Site Number 392120, Ota-Ku, Japan|Investigational Site Number 392157, Ota-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 392058, Saitama-Shi, Japan|Investigational Site Number 392074, Sanda-Shi, Japan|Investigational Site Number 392047, Sapporo-Shi, Japan|Investigational Site Number 392106, Sapporo-Shi, Japan|Investigational Site Number 392097, Sasebo-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 392110, Shinagawa-Ku, Japan|Investigational Site Number 392021, Shinjuku-Ku, Japan|Investigational Site Number 392098, Shinjuku-Ku, Japan|Investigational Site Number 392104, Shiogama-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 392156, Takatsuki-Shi, Japan|Investigational Site Number 392061, Tokorozawa-Shi, Japan|Investigational Site Number 392111, Tomakomai-Shi, Japan|Investigational Site Number 392073, Tsu-Shi, Japan|Investigational Site Number 392063, Ube-Shi, Japan|Investigational Site Number 392124, Ushiku-Shi, Japan|Investigational Site Number 392067, Yatsushiro-Shi, Japan|Investigational Site Number 392085, Yokohama-Shi, Japan|Investigational Site Number 392126, Yokohama-Shi, Japan|Investigational Site Number 392035, Zentsuji-Shi, Japan
URL: https://clinicaltrials.gov/show/NCT02752412

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details