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24-week Study Comparing Lixisenatide (AVE0010) to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50

2014-07-23 21:13:20 | BioPortfolio

Summary

The primary objective of this study is to assess the efficacy of lixisenatide (AVE0010) on a composite endpoint of glycemic control (HbA1c) and body weight in comparison to sitagliptin as an add-on treatment to metformin over a period of 24 weeks in obese type 2 diabetic patients younger than 50.

Secondary Objectives:

To assess the effects of AVE0010 on:

- Absolute changes in HbA1c and body weight

- Fasting plasma glucose

- Plasma glucose, insulin, C peptide, glucagon and proinsulin during a 2-hour standardized meal test

- Insulin resistance assessed by HOMA-IR

- Beta cell function assessed by HOMA-beta

- To assess AVE0010 safety and tolerability

- To assess AVE0010 PK using the population PK approach and to assess anti-AVE0010 antibody development

Description

Maximum duration of 27 weeks ± 7 days (3-week screening + 24- week double-blind, double-dummy, active-controlled treatment + 3- day follow-up)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Type 2 Diabetes Mellitus

Intervention

Lixisenatide (AVE0010), Sitagliptin

Location

Sanofi-Aventis Investigational Site Number 840019
Montgomery
Alabama
United States
36109

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:20-0400

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Medical and Biotech [MESH] Definitions

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.

A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).

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