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GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO)
This study is currently recruiting participants.
Verified by Sanofi-Aventis, January 2009
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00688701
  Purpose

The purpose of this study is to evaluate the benefits and risks of AVE0010 in monotherapy in comparison to placebo, over a period of 12 weeks of treatment.

The primary objective is to assess the effects of AVE0010 on glycemic control in terms of HbA1c reduction at 12 weeks.

Secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma glucose, post-prandial plasma glucose changes, and to assess the safety and tolerability of AVE0010.


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

MedlinePlus related topics: Diabetes
Drug Information available for: Glucagon-like peptide 1
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, Parallel-Group, Multicenter 12-Week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Absolute change from baseline in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in 2-hours post-prandial plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: May 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: AVE0010
12 weeks of treatment
2: Placebo Comparator Drug: Placebo
12 weeks of treatment

  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 not treated with any antidiabetic agent

Exclusion Criteria:

  • HbA1c < 7% or > 10%
  • Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
  • Type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study
  • 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: NCT00688701

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    
Belgium
Sanofi-Aventis Administrative Office Recruiting
Diegem, Belgium
Contact         GV-Contact-us@sanofi-aventis.com    
India
Sanofi-Aventis Administrative Office Recruiting
Mumbai, India
Contact         GV-Contact-us@sanofi-aventis.com    
Japan
Sanofi-Aventis Administrative Office Recruiting
Tokyo, Japan
Contact         GV-Contact-us@sanofi-aventis.com    
Korea, Republic of
Sanofi-Aventis Administrative Office Recruiting
Seoul, Korea, Republic of
Contact         GV-Contact-us@sanofi-aventis.com    
Mexico
Sanofi-Aventis Administrative Office Recruiting
Mexico, Mexico
Contact         GV-Contact-us@sanofi-aventis.com    
Poland
Sanofi-Aventis Administrative Office Recruiting
Warszawa, Poland
Contact         GV-Contact-us@sanofi-aventis.com    
Romania
Sanofi-Aventis Administrative Office Recruiting
Bucuresti, Romania
Contact         GV-Contact-us@sanofi-aventis.com    
Russian Federation
Sanofi-Aventis Administrative Office Recruiting
Moscow, Russian Federation
Contact         GV-Contact-us@sanofi-aventis.com    
Tunisia
Sanofi-Aventis Administrative Office Recruiting
Megrine, Tunisia
Contact         GV-Contact-us@sanofi-aventis.com    
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD CSD Sanofi-Aventis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: sanofi-aventis ( International Clinical Development Study Director )
Study ID Numbers: EFC6018, EudraCT 2007-005887-29
Study First Received: May 7, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00688701  
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
Metabolic disorder
Glucose Metabolism Disorders
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on January 16, 2009



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