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Clinical Trial Details

Trial ID: L3301
Source ID: NCT01940965
Associated Drug: Lixisenatide Ave0010
Title: Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: lixisenatide AVE0010|DRUG: biguanide|DRUG: TZD|DRUG: alpha-GI|DRUG: glinide
Outcome Measures: Primary: Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data, 52 weeks | Secondary: Absolute change in HbA1c, From baseline to weeks 24 and 52|Absolute change in fasting plasma glucose, From baseline to weeks 24 and 52|Absolute change in body weight, From baseline to weeks 24 and 52
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 294
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-09
Completion Date: 2015-07
Results First Posted:
Last Update Posted: 2015-08-04
Locations: Investigational Site Number 392335, Adachi-Ku, Japan|Investigational Site Number 392325, Chiba-Shi, Japan|Investigational Site Number 392328, Chiyoda-Ku, Japan|Investigational Site Number 392326, Chuo-Ku, Japan|Investigational Site Number 392327, Chuo-Ku, Japan|Investigational Site Number 392310, Chuoh-Ku, Japan|Investigational Site Number 392336, Kagoshima-Shi, Japan|Investigational Site Number 392314, Kamakura-Shi, Japan|Investigational Site Number 392334, Kashiwara-Shi, Japan|Investigational Site Number 392304, Kawagoe-Shi, Japan|Investigational Site Number 392306, Kawaguchi-Shi, Japan|Investigational Site Number 392307, Kisarazu-Shi, Japan|Investigational Site Number 392301, Koriyama-Shi, Japan|Investigational Site Number 392312, Mitaka-Shi, Japan|Investigational Site Number 392302, Mito-Shi, Japan|Investigational Site Number 392324, Mito-Shi, Japan|Investigational Site Number 392331, Nagoya-Shi, Japan|Investigational Site Number 392332, Nagoya-Shi, Japan|Investigational Site Number 392329, Ohta-Ku, Japan|Investigational Site Number 392322, Okawa-Shi, Japan|Investigational Site Number 392333, Osaka-Shi, Japan|Investigational Site Number 392330, Sagamihara-Shi, Japan|Investigational Site Number 392320, Saijo-Shi, Japan|Investigational Site Number 392303, Sakado-Shi, Japan|Investigational Site Number 392311, Shinjuku-Ku, Japan|Investigational Site Number 392316, Shizuoka-Shi, Japan|Investigational Site Number 392319, Suita-Shi, Japan
URL: https://clinicaltrials.gov/show/NCT01940965

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress