GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00866658
First received: March 19, 2009
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 basal insulin with or without sulfonylurea in comparison to placebo, over a period of 24 weeks of treatment.
The primary objective is to assess the effects of AVE0010 on glycemic control in terms of glycosylated hemoglobin A1c (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: Sulfonylurea |
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 Treatment Period Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without 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:
- Change from baseline in body weight [ 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 ]
- Change from baseline in Fasting Plasma Glucose (FPG) [ 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 ]
- Change from baseline in basal insulin daily dose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Percentage of patients requiring rescue therapy during the study [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 311 |
| Study Start Date: | March 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
24 weeks of AVE0010 on top of basal insulin with or without sulfonylurea
|
Drug: Lixisenatide (AVE0010)
subcutaneous injection
Drug: Basal Insulin
To be continued throughout the study as used before study start
Drug: Sulfonylurea
If given, to be continued throughout the study as used before study start
|
|
Placebo Comparator: 2
24 weeks of placebo on top of basal insulin with or without sulfonylurea
|
Drug: Placebo
subcutaneous injection
Drug: Basal Insulin
To be continued throughout the study as used before study start
Drug: Sulfonylurea
If given, to be continued throughout the study as used before study start
|
Eligibility| Ages Eligible for Study: | 20 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 sulfonylurea
Exclusion Criteria:
- HbA1c <7% or >10%
- Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
- Treatment with basal insulin for less than 3 months before screening
- Basal insulin dose at screening < 10 U/day and/or during the last 2 months dose not stable (± 20%)
- 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: NCT00866658
Locations
| Japan | |
| Sanofi-Aventis Administrative Office | |
| Tokyo, Japan | |
| Korea, Republic of | |
| Sanofi-Aventis Administrative Office | |
| Seoul, Korea, Republic of | |
| Philippines | |
| Sanofi-Aventis Administrative Office | |
| Makati City, Philippines | |
| Taiwan | |
| Sanofi-Aventis Administrative Office | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
Publications:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00866658 History of Changes |
| Other Study ID Numbers: | EFC10887 |
| Study First Received: | March 19, 2009 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Sanofi:
|
hyperglycemia GLP-1 sulfonylurea insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013