GLP-1 Agonist AVE0010 Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin - Full Text View

Purpose

The purpose of this study is to compare the benefits and risks of AVE0010 versus exenatide in association with metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of AVE0010 on glycemic control in terms of HbA1c reduction at 24 weeks.

The secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma glucose, relevant metabolic parameters in type 2 diabetes, and to evaluate safety, tolerability and quality of life.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: AVE0010 Drug: Exenatide	Phase III

MedlinePlus related topics:

Diabetes

Drug Information available for:

Exenatide Metformin Metformin hydrochloride Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	A Randomized, Open-Label, Active-Controlled, 2-Arm Parallel-Group, Multicenter 24-Week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 Versus Exenatide on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Quality of Life: change in patient's satisfaction to treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	June 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AVE0010 At least 24 weeks of treatment extension period of variable duration
2: Active Comparator	Drug: Exenatide At least 24 weeks of treatment extension period of variable duration

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with metformin

Exclusion Criteria:

HbA1c <7% or >10%
Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to screening
Body mass index < 20 kg/m2
Weight change of more than 5 kg during the 3 months preceding the study
Participation in any previous study with AVE0010
Use of any investigational drug within 3 months prior to study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707031

Contacts


Contact: Public Registry ICD		GV-Contact-us@sanofi-aventis.com

Locations


United States, New Jersey
	Sanofi-Aventis Administrative Office	Recruiting
	Bridgewater, New Jersey, United States, 08807
	Contact GV-Contact-us@sanofi-aventis.com

Austria
	Sanofi-Aventis Administrative Office	Recruiting
	Wien, Austria
	Contact GV-Contact-us@sanofi-aventis.com

Colombia
	Sanofi-Aventis Administrative Office	Recruiting
	Santafe de Bogota, Colombia
	Contact GV-Contact-us@sanofi-aventis.com

Denmark
	Sanofi-Aventis Administrative Office	Recruiting
	Horsholm, Denmark
	Contact GV-Contact-us@sanofi-aventis.com

Finland
	Sanofi-Aventis Administrative Office	Recruiting
	Helsinki, Finland
	Contact GV-Contact-us@sanofi-aventis.com

Germany
	Sanofi-Aventis Administrative Office	Recruiting
	Berlin, Germany
	Contact GV-Contact-us@sanofi-aventis.com

Hungary
	Sanofi-Aventis Administrative Office	Recruiting
	Budapest, Hungary
	Contact GV-contact-us@sanofi-aventis.com

Italy
	Sanofi-Aventis Administrative Office	Recruiting
	Milano, Italy
	Contact GV-Contact-us@sanofi-aventis.com

Netherlands
	Sanofi-Aventis Administrative Office	Recruiting
	Gouda, Netherlands
	Contact GV-Contact-us@sanofi-aventis.com

Puerto Rico
	Sanofi-Aventis Administrative Office	Recruiting
	Puerto Rico, Puerto Rico
	Contact GV-Contact-us@sanofi-aventis.com

Russian Federation
	Sanofi-Aventis Administrative Office	Recruiting
	Moscow, Russian Federation
	Contact GV-Contact-us@sanofi-aventis.com

Spain
	Sanofi-Aventis Administrative Office	Recruiting
	Barcelona, Spain
	Contact GV-Contact-us@sanofi-aventis.com

Sweden
	Sanofi-Aventis Administrative Office	Recruiting
	Bromma, Sweden
	Contact GV-Contact-us@sanofi-aventis.com

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	ICD	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6019, EudraCT 2007-005883-28
First Received:	June 26, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00707031
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

hyperglycemia, GLP-1, metformin

Study placed in the following topic categories:

Metabolic Diseases

Hyperglycemia

Exenatide

Metformin

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Glucagon-Like Peptide 1

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00707031