GLP-1 Agonist AVE0010 (Morning or Evening) 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 evaluate the benefits and risks of AVE0010 in association 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 when it is used in the morning or in the evening 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, and to evaluate safety and tolerability.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Lixisenatide (AVE0010) Drug: Placebo 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, Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

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:

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 ]
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 ]
Change from baseline in body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	680
Study Start Date:	June 2008
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lixisenatide morning Administered in the morning	Drug: Lixisenatide (AVE0010) At least 24 weeks of treatment, extension period of variable duration Drug: Metformin continued at a stable dose throughout the study
Placebo Comparator: placebo morning Administered in the morning	Drug: Placebo At least 24 weeks of treatment, extension period of variable duration Drug: Metformin continued at a stable dose throughout the study
Experimental: lixisenatide evening Administered in the evening	Drug: Lixisenatide (AVE0010) At least 24 weeks of treatment, extension period of variable duration Drug: Metformin continued at a stable dose throughout the study
Placebo Comparator: placebo evening Administered in the evening	Drug: Placebo 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: NCT00712673

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Australia
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, Australia
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Morocco
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Ukraine
Sanofi-Aventis Administrative Office
Kiev, Ukraine
Venezuela
Sanofi-Aventis Administrative Office
Caracas, Venezuela

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00712673 History of Changes
Other Study ID Numbers:	EFC6014, EudraCT 2007-005880-80
Study First Received:	July 7, 2008
Last Updated:	April 13, 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

Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

GLP-1 Agonist AVE0010 (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin (GETGOAL-M)