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NCT00707031 · ClinicalTrials.gov registry record · Phase 3
GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 639
- Enrollment target
NCT00707031: Completed Phase 3 study, sponsored by Sanofi.
NCT00707031 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 639 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00707031, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 639 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), 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 in comparison to exenatide (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life \[PAGI-QOL\]).
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 11 (Week 24) or Day 169 if Visit 11 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.
Interventions
- DRUG Metformin
- DRUG Exenatide
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
- DEVICE Prefilled pen injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 639 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00707031 record still lists
NCT00707031 is an interventional study that assigns participants to a tested intervention. The registered 639 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Metformin is the first listed.
NCT00707031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00707031 about?
NCT00707031 is a clinical study titled "GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin". The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), 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 in com...
What is the current status of trial NCT00707031?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 639 participants. The study started on 2008-06. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00707031?
The interventions under investigation include: Metformin (DRUG), Exenatide (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE), Prefilled pen injector (DEVICE).
Who is sponsoring clinical trial NCT00707031?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00707031's enrollment target sits among peer trials
639 579th of 2000 higher than 1,422 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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