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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00713830

Purpose

The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with sulfonylurea without or with metformin in comparison to placebo, 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.

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

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

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel-Group, Multicenter 24-Week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of a Sulfonylurea in Patients With Type 2 Diabetes Not Adequately Controlled With Sulfonylurea

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 ]
Change from baseline in 2-hours post-prandial plasma glucose, glucagon, insulin, pro-insulin, C-peptide [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	855
Study Start Date:	July 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 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: Placebo Comparator	Drug: Placebo 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 a sulfonylurea alone or a sulfonylurea in association with metformin

Exclusion Criteria:

HbA1c < 7% or > 10%
Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
Sulfonylurea not at a stable (unchanged) dose for at least 3 months prior to screening and less than the maximal effective dose according to local labeling
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: NCT00713830

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
Bulgaria
Sanofi-Aventis Administrative Office	Recruiting
Sofia, Bulgaria
Czech Republic
Sanofi-Aventis Administrative Office	Recruiting
Praha, Czech Republic
Egypt
Sanofi-Aventis Administrative Office	Recruiting
Cairo, Egypt
Germany
Sanofi-Aventis Administrative Office	Recruiting
Berlin, Germany
India
Sanofi-Aventis Administrative Office	Recruiting
Mumbai, India
Israel
Sanofi-Aventis Administrative Office	Recruiting
Natanya, Israel
Japan
Sanofi-Aventis Administrative Office	Recruiting
Tokyo, Japan
Korea, Republic of
Sanofi-Aventis Administrative Office	Recruiting
Seoul, Korea, Republic of
Netherlands
Sanofi-Aventis Administrative Office	Recruiting
Gouda, Netherlands
Romania
Sanofi-Aventis Administrative Office	Recruiting
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office	Recruiting
Moscow, Russian Federation
Taiwan
Sanofi-Aventis Administrative Office	Recruiting
Taipei, Taiwan
Thailand
Sanofi-Aventis Administrative Office	Recruiting
Bangkok, Thailand
Tunisia
Sanofi-Aventis Administrative Office	Recruiting
Megrine, Tunisia
Turkey
Sanofi-Aventis Administrative Office	Recruiting
Istanbul, Turkey

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6015, EudraCT 2007-005881-11
Study First Received:	July 10, 2008
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00713830 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

hyperglycemia, GLP-1

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Glucagon-Like Peptide 1

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009