GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea (GETGOAL-S)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00713830
First received: July 10, 2008
Last updated: September 25, 2012
Last verified: September 2012
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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 glycosylated hemoglobin A1c (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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Lixisenatide (AVE0010) Drug: Placebo Drug: Sulfonylurea 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 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 Sulfonylurea |
Resource links provided by NLM:
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 body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in 2-hour post-prandial plasma glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Fasting Plasma Glucose (FPG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in β-cell function assessed by homeostasis model assessment (HOMA-β) [ 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: | 859 |
| Study Start Date: | July 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 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: Sulfonylurea
maximum effective dose according to local labeling
Drug: Metformin
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
|
| Placebo Comparator: placebo |
Drug: Placebo
at least 24 weeks of treatment, extension period of variable duration
Drug: Sulfonylurea
maximum effective dose according to local labeling
Drug: Metformin
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
|
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713830
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Bulgaria | |
| Sanofi-Aventis Administrative Office | |
| Sofia, Bulgaria | |
| Czech Republic | |
| Sanofi-Aventis Administrative Office | |
| Praha, Czech Republic | |
| Egypt | |
| Sanofi-Aventis Administrative Office | |
| Cairo, Egypt | |
| Germany | |
| Sanofi-Aventis Administrative Office | |
| Berlin, Germany | |
| India | |
| Sanofi-Aventis Administrative Office | |
| Mumbai, India | |
| Israel | |
| Sanofi-Aventis Administrative Office | |
| Natanya, Israel | |
| Japan | |
| Sanofi-Aventis Administrative Office | |
| Tokyo, Japan | |
| Korea, Republic of | |
| Sanofi-Aventis Administrative Office | |
| Seoul, Korea, Republic of | |
| Netherlands | |
| Sanofi-Aventis Administrative Office | |
| Gouda, Netherlands | |
| Romania | |
| Sanofi-Aventis Administrative Office | |
| Bucuresti, Romania | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
| Taiwan | |
| Sanofi-Aventis Administrative Office | |
| Taipei, Taiwan | |
| Thailand | |
| Sanofi-Aventis Administrative Office | |
| Bangkok, Thailand | |
| Tunisia | |
| Sanofi-Aventis Administrative Office | |
| Megrine, Tunisia | |
| Turkey | |
| Sanofi-Aventis Administrative Office | |
| Istanbul, Turkey | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00713830 History of Changes |
| Other Study ID Numbers: | EFC6015, EudraCT 2007-005881-11 |
| Study First Received: | July 10, 2008 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
hyperglycemia, GLP-1 |
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 June 13, 2013