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NCT00688701 · ClinicalTrials.gov registry record · Phase 3
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 361
- Enrollment target
NCT00688701: Completed Phase 3 study, sponsored by Sanofi.
NCT00688701 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 361 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00688701, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 361 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12. Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Primary Outcome
Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 Placebo
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00688701 record still lists
NCT00688701 is an interventional study that assigns participants to a tested intervention. The registered 361 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 (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00688701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00688701 about?
NCT00688701 is a clinical study titled "GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy". The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to place...
What is the current status of trial NCT00688701?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 361 participants. The study started on 2008-05. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00688701?
The interventions under investigation include: Placebo (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE).
Who is sponsoring clinical trial NCT00688701?
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 NCT00688701's enrollment target sits among peer trials
361 1008th of 2000 higher than 993 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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