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Clinical Trial Details

Trial ID: L5189
Source ID: NCT01960179
Associated Drug: Lixisenatide Ave0010
Title: Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: lixisenatide AVE0010
Outcome Measures: Primary: Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data., from baseline to 24 weeks and 52 weeks | Secondary: Absolute change in HbA1c, from baseline to week 24 and week 52|Absolute change in fasting plasma glucose, from baseline to week 24 and week 52|Absolute change in body weight, from baseline to week 24 and week 52
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 361
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-11
Completion Date: 2015-03
Results First Posted:
Last Update Posted: 2015-04-09
Locations: Investigational Site Number 392006, Adachi-Ku, Japan|Investigational Site Number 392005, Chiba-Shi, Japan|Investigational Site Number 392010, Chiyoda-Ku, Japan|Investigational Site Number 392004, Chuo-Ku, Japan|Investigational Site Number 392015, Chuo-Ku, Japan|Investigational Site Number 392003, Chuoh-Ku, Japan|Investigational Site Number 392012, Ebina-Shi, Japan|Investigational Site Number 392024, Higashiosaka-Shi, Japan|Investigational Site Number 392023, Kashiwara-Shi, Japan|Investigational Site Number 392008, Kawagoe-Shi, Japan|Investigational Site Number 392009, Kisarazu-Shi, Japan|Investigational Site Number 392002, Koganei-Shi, Japan|Investigational Site Number 392007, Koriyama-Shi, Japan|Investigational Site Number 392011, Mitaka-Shi, Japan|Investigational Site Number 392025, Nagoya-Shi, Japan|Investigational Site Number 392026, Nagoya-Shi, Japan|Investigational Site Number 392013, Ogawa-Machi, Hikigun, Japan|Investigational Site Number 392014, Ohta-Ku, Japan|Investigational Site Number 392022, Okawa-Shi, Japan|Investigational Site Number 392021, Osaka-Shi, Japan|Investigational Site Number 392028, Osaka-Shi, Japan|Investigational Site Number 392029, Osaka-Shi, Japan|Investigational Site Number 392030, Sapporo-Shi, Japan|Investigational Site Number 392018, Sendai-Shi, Japan|Investigational Site Number 392001, Shinjuku-Ku, Japan|Investigational Site Number 392020, Suita-Shi, Japan|Investigational Site Number 392017, Toshima-Ku, Japan|Investigational Site Number 392027, Toyonaka-Shi, Japan|Investigational Site Number 392016, Yokohama-Shi, Japan|Investigational Site Number 392019, Yokohama-Shi, Japan
URL: https://clinicaltrials.gov/show/NCT01960179

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress