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

Phase 2

Terminated

• Conditions: Type II Diabetes Mellitus
• Interventions: Drug: LIXISENATIDE AVE0010; Drug: metformin

• Registration Number: NCT02274740
• Lead Sponsor: Sanofi

Brief 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).

Study Timeline

• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Study Start: 2015-04
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lixisenatide	LIXISENATIDE AVE0010	Lixisenatide injection should be performed in the morning, within 1 hour (ie, 0-60 minutes), prior to breakfast (or standardized meal). Lixisenatide is to be started with once daily injections of 10 μg per day for 2 weeks then to be continued by the maintenance dose (8 weeks) of 20 μg/d up to the end of the treatment period.
lixisenatide	metformin	Lixisenatide injection should be performed in the morning, within 1 hour (ie, 0-60 minutes), prior to breakfast (or standardized meal). Lixisenatide is to be started with once daily injections of 10 μg per day for 2 weeks then to be continued by the maintenance dose (8 weeks) of 20 μg/d up to the end of the treatment period.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in plasma cholesterol	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 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 plasma triglyceride	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 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
Change from baseline in APO B48	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 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