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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 639 participants.
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 \[PAGI-QOL\]).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00707031
The ClinicalTrials.gov registry entry for NCT00707031 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 639 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 Metformin is the first listed.
NCT00707031 reports 0 study locations.
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.
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