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Clinical Trial Details

Trial ID: L3777
Source ID: NCT02274740
Associated Drug: Lixisenatide Ave0010
Title: Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: LIXISENATIDE AVE0010|DRUG: metformin
Outcome Measures: Primary: Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min), After 10 weeks of treatment | Secondary: Change from baseline in plasma triglyceride, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in plasma cholesterol, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in APO B48, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in free fatty acid levels, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in lipoprotein distribution, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in LDL oxidation, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in postprandial plasma glucose, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in insulin, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in C-peptide, 2 days after the basal test and after 10 weeks of treatment|Change from baseline in low grade inflammation (cytokines and stress oxidative markers), 2 days after the basal test and after 10 weeks of treatment|Change in baseline coronary flow reserve to assess the effect of lixisenatide on microvascular dysfunction, 2 days after the basal test and after 10 weeks of treatment
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 2
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-04
Completion Date: 2015-08
Results First Posted:
Last Update Posted: 2017-01-30
Locations:
URL: https://clinicaltrials.gov/show/NCT02274740