Expired Study
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Bridgewater, New Jersey 08807


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.


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.


Study is Available At:


Original ID:

EFC6015


NCT ID:

NCT00713830


Secondary ID:

EudraCT 2007-005881-11


Study Acronym:

GETGOAL-S


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi-Aventis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

859


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Sciences & Operations
Study Director
Sanofi-Aventis

Study Dates

Start Date:July 2008
Completion Date:January 2011
Completion Type:Actual
Primary Completion Date:January 2011
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 27, 2012
First Received Date:July 10, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline in 2-hours post-prandial plasma glucose, glucagon, insulin, pro-insulin, C-peptide
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in fasting plasma glucose
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in body weight
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Absolute change from baseline in HbA1c
Time Frame:24 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Lixisenatide (AVE0010)
Description:at least 24 weeks of treatment, extension period of variable duration
Arm Name:lixisenatide
Intervention Type:Drug
Name:Placebo
Description:at least 24 weeks of treatment, extension period of variable duration
Arm Name:placebo
Intervention Type:Drug
Name:Sulfonylurea
Description:maximum effective dose according to local labeling
Arm Name:lixisenatide
Intervention Type:Drug
Name:Metformin
Description:dose to be kept stable throughout the entire study. If not used at screening, metformin not allowed during the study except as rescue therapy per protocol definition
Arm Name:lixisenatide

Study Arms

Study Arm Type:Experimental
Arm Name:lixisenatide
Study Arm Type:Placebo Comparator
Arm Name:placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sanofi-Aventis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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