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 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.


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.


Study is Available At:


Original ID:

EFC6016


NCT ID:

NCT00715624


Secondary ID:

2007-005886-36


Study Acronym:

GETGOAL-L


Brief Title:

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


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 Basa


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:

496


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:July 2008
Completion Date:February 2011
Completion Type:Actual
Primary Completion Date:February 2011
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 12, 2012
First Received Date:July 11, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline in 7-point Self Monitored Plasma Glucose (SMPG) profiles
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients requiring rescue therapy during main 24-week period
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients with HbA1c ≤6.5% at Week 24
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients with HbA1c <7% at Week 24
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in 2-hour postprandial plasma glucose after standardized test meal
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in insulin doses
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:Basal Insulin
Description:Basal insulin to be continued throughout the study as used before entering the study
Arm Name:lixisenatide
Intervention Type:Drug
Name:Metformin
Description:If given, metformin to be continued at a stable dose of 1.5 g/day throughout the study
Arm Name:lixisenatide

Study Arms

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

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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