GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00688701
First received: May 7, 2008
Last updated: January 3, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to evaluate the benefits and risks of AVE0010 in monotherapy in comparison to placebo, over a period of 12 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 12 weeks.
Secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma glucose, post-prandial plasma glucose changes, and to assess the safety and tolerability of AVE0010.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: lixisenatide (AVE0010) Drug: placebo Device: insulin auto-injector |
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 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Absolute change from baseline in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of patients with HbA1c < 7% at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percentage of patients with HbA1c ≤ 6.5% at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in 2-hours post-prandial plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percentage of patients requiring rescue therapy during the double-blind treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 361 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Two-step Titration
10 μg once daily (QD) injections of volume-matched placebo for 1 week, then 15 μg QD injections volume-matched placebo for 1 week followed by the maintenance dose of 20 μg QD injections of volume-matched placebo from Week 3 up to Week 12
|
Drug: placebo
self-administered by subcutaneous injections once daily within the hour preceding breakfast and using an injector device
Device: insulin auto-injector
Other Name: OptiClik®
|
|
Placebo Comparator: Placebo One-step Titration
10 μg QD injections of volume-matched placebo for 2 weeks followed by the maintenance dose of 20 μg QD injections of volume-matched placebo from Week 3 up to Week 12
|
Drug: placebo
self-administered by subcutaneous injections once daily within the hour preceding breakfast and using an injector device
Device: insulin auto-injector
Other Name: OptiClik®
|
|
Experimental: Lixisenatide Two-step Titration
10 μg QD injections of lixisenatide for 1 week, then 15 μg QD injections of lixisenatide for 1 week followed by the maintenance dose of 20 μg QD injections of lixisenatide from Week 3 up to Week 12
|
Drug: lixisenatide (AVE0010)
self-administered by subcutaneous injections once daily within the hour preceding breakfast and using an injector device
Device: insulin auto-injector
Other Name: OptiClik®
|
|
Experimental: Lixisenatide One-step Titration
10 μg QD injections of lixisenatide for 2 weeks followed by the maintenance dose of 20 μg QD injections of lixisenatide from Week 3 up to Week 12
|
Drug: lixisenatide (AVE0010)
self-administered by subcutaneous injections once daily within the hour preceding breakfast and using an injector device
Device: insulin auto-injector
Other Name: OptiClik®
|
Detailed Description:
This is a double-blind, randomized, placebo-controlled, 4-arm, unbalanced design, parallel group study with a 2-step titration regimen or a 1-step titration regimen. The study is double-blind with regard to active and placebo treatments; however neither the study drug volume nor the titration regimens (ie, 2-step or 1-step) are blinded.
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 not treated with any antidiabetic agent
Exclusion Criteria:
- HbA1c < 7% or > 10%
- Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
- Type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study
- 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: NCT00688701
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Belgium | |
| Sanofi-Aventis Administrative Office | |
| Diegem, Belgium | |
| 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 | |
| Mexico | |
| Sanofi-Aventis Administrative Office | |
| Mexico, Mexico | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warszawa, Poland | |
| Romania | |
| Sanofi-Aventis Administrative Office | |
| Bucuresti, Romania | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
| Tunisia | |
| Sanofi-Aventis Administrative Office | |
| Megrine, Tunisia | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
Publications:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00688701 History of Changes |
| Other Study ID Numbers: | EFC6018, EudraCT 2007-005887-29 |
| Study First Received: | May 7, 2008 |
| Last Updated: | January 3, 2013 |
| 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 Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013