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NCT00713830 · 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 Sulfonylurea
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 859
- Enrollment target
NCT00713830: Completed Phase 3 study, sponsored by Sanofi.
NCT00713830 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 859 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00713830, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 859 participants
- Enrollment target
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 sulfonylurea without or with 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 sulfonylurea with or without 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 (%); percentage of patients reaching HbA1c less than or equal to (\<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate 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 Modified Intent-to-Treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable,
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Sulfonylurea
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 859 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
What the finished NCT00713830 record still lists
NCT00713830 is an interventional study that assigns participants to a tested intervention. The registered 859 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00713830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00713830 about?
NCT00713830 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 Sulfonylurea". 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 sulfonylurea without or with metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of ...
What is the current status of trial NCT00713830?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 859 participants. The study started on 2008-07. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00713830?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Sulfonylurea (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE).
Who is sponsoring clinical trial NCT00713830?
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 NCT00713830's enrollment target sits among peer trials
859 383rd of 2000 higher than 1,618 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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