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GLP-1 Agonist AVE0010 Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin (GETGOAL-X)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00707031
First received: June 26, 2008
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  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: Lixisenatide (AVE0010)
Drug: Exenatide
Drug: Metformin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]
  • Percentage of patients with HbA1c <7% at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c ≤6.5% at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients requiring rescue therapy during main 24-week period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 639
Study Start Date: June 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lixisenatide Drug: Lixisenatide (AVE0010)
At least 24 weeks of treatment extension period of variable duration
Drug: Metformin
continued at a stable dose throughout the study
Active Comparator: exenatide Drug: Exenatide
At least 24 weeks of treatment extension period of variable duration
Drug: Metformin
continued at a stable dose throughout the study

  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

  Show 18 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00707031     History of Changes
Other Study ID Numbers: EFC6019, 2007-005883-28
Study First Received: June 26, 2008
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
hyperglycemia, GLP-1, metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Exenatide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013