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NCT00763815 · 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 Pioglitazone
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 484
- Enrollment target
NCT00763815 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 484 participants.
The verdict
NCT00763815, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 484 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 pioglitazone with or without 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 pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function \[HOMA-beta\]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Pioglitazone
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2008-09 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00763815
The ClinicalTrials.gov registry entry for NCT00763815 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00763815 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00763815 about?
NCT00763815 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 Pioglitazone". 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 pioglitazone with or without 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 NCT00763815?
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 2011-06.
What interventions are being tested in trial NCT00763815?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Pioglitazone (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE).
Who is sponsoring clinical trial NCT00763815?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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