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GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin (GETGOAL-L)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00715624
First received: July 11, 2008
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with basal insulin with or without 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.

The secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma glucose, insulin doses, and to evaluate safety and tolerability.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Basal Insulin
Drug: Metformin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin

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 ]
  • Change from baseline in insulin doses [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in 2-hour postprandial plasma glucose after standardized test meal [ 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 ]
  • Change from baseline in 7-point Self Monitored Plasma Glucose (SMPG) profiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 496
Study Start Date: July 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (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: Basal Insulin
Basal insulin to be continued throughout the study as used before entering the study
Drug: Metformin
If given, metformin to be continued at a stable dose of 1.5 g/day throughout the study
Placebo Comparator: placebo Drug: Placebo
At least 24 weeks of treatment, extension period of variable duration
Drug: Basal Insulin
Basal insulin to be continued throughout the study as used before entering the study
Drug: Metformin
If given, metformin to be continued at a stable dose of 1.5 g/day 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 basal insulin with or without metformin

Exclusion Criteria:

  • HbA1c <7% or >10%
  • Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
  • Basal insulin < 30 U/day or not at a stable dose (± 20%) 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: NCT00715624

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Egypt
Sanofi-Aventis Administrative Office
Cairo, Egypt
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
India
Sanofi-Aventis Administrative Office
Mumbai, India
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Puerto Rico
Sanofi-Aventis Administrative Office
Puerto Rico, Puerto Rico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00715624     History of Changes
Other Study ID Numbers: EFC6016, 2007-005886-36
Study First Received: July 11, 2008
Last Updated: October 12, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2013