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NCT00763451 · ClinicalTrials.gov registry record · Phase 3
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 484
- Enrollment target
- 15
- Study locations
NCT00763451: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.
NCT00763451 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Sanofi. The registered enrollment target is 484 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The trial reports 15 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00763451, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 484 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Primary Outcome
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. The "Place
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
Study Locations (15)
Other
- Sanofi-Aventis Administrative Office - São Paulo
- Sanofi-Aventis Administrative Office - Santiago
- Sanofi-Aventis Administrative Office - Bogotá
- Sanofi-Aventis Administrative Office - Tallinn
- Sanofi-Aventis Administrative Office - Berlin
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Vilnius
- Sanofi-Aventis Administrative Office - Kuala Lumpur
- Sanofi-Aventis Administrative Office - México
- Sanofi-Aventis Administrative Office - Makati City
- Sanofi-Aventis Administrative Office - Warsaw
- Sanofi-Aventis Administrative Office - Bucharest
- Sanofi-Aventis Administrative Office - Brastislava
- Sanofi-Aventis Administrative Office - Kiev
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2008-09 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
What the finished NCT00763451 record still lists
NCT00763451 is an interventional study that assigns participants to a tested intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00763451 lists 15 locations in 2 states (Other, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00763451 about?
NCT00763451 is a clinical study titled "GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin". The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to me...
What is the current status of trial NCT00763451?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 484 participants. The study started on 2008-09. Estimated completion is 2011-01.
What conditions does trial NCT00763451 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT00763451?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE).
Who is sponsoring clinical trial NCT00763451?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00763451 being conducted?
This trial has 15 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00763451's enrollment target sits among peer trials
484 81st of 348 higher than 268 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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