Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2173
Source ID: NCT02200991
Associated Drug: Lixisenatide Ave0010
Title: Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: LIXISENATIDE AVE0010|DRUG: Sitagliptin|DRUG: Insulin glargine HOE901
Outcome Measures: Primary: Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast, Day 29 after first intake of investigational product | Secondary: Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast, Day 29 after first intake of investigational product|Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast, Day 29 after first intake of investigational product|Change from baseline in glucagon levels at Day 29 after a standardized breakfast, Day 29 after first intake of investigational product|Change in gastric emptying half life (13C-acetic acid breath test), Day 29 after first intake of investigational product|Proportion of patients with adverse events, Up to Day 33 from the first intake of investigational medicinal product
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 136
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-08
Completion Date: 2015-11
Results First Posted:
Last Update Posted: 2016-10-05
Locations: Investigational Site Number 392-107, Atsugi-shi, Japan|Investigational Site Number 392-125, Chiyoda-ku, Japan|Investigational Site Number 392-121, Chuoh-ku, Japan|Investigational Site Number 392-102, Ichihara-shi, Japan|Investigational Site Number 392-103, Kawaguchi-shi, Japan|Investigational Site Number 392-114, Kitamoto-shi, Japan|Investigational Site Number 392-122, Kobe-shi, Japan|Investigational Site Number 392-126, Kumamoto-shi, Japan|Investigational Site Number 392-127, Kumamoto-shi, Japan|Investigational Site Number 392-101, Kyoto-shi, Japan|Investigational Site Number 392-106, Matsudo-shi, Japan|Investigational Site Number 392-124, Mitaka-shi, Japan|Investigational Site Number 392-108, Mito-shi, Japan|Investigational Site Number 392-119, Nerima-ku, Japan|Investigational Site Number 392-117, Okayama-shi, Japan|Investigational Site Number 392-111, Sagamihara-shi, Japan|Investigational Site Number 392-110, Sapporo-shi, Japan|Investigational Site Number 392-116, Satsumasendai-shi, Japan|Investigational Site Number 392-105, Shizuoka-shi, Japan|Investigational Site Number 392-118, Suita-shi, Japan
URL: https://clinicaltrials.gov/show/NCT02200991

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress