NCT02274740

Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides. Secondary Objectives: The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation. The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity. The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.

Detailed description

Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (Final/End-of-treatment Visit).

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	LIXISENATIDE AVE0010	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	metformin	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-10-24
• Last updated: 2017-01-30