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NCT00715624 · 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 Basal Insulin
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 496
- Enrollment target
NCT00715624 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 496 participants.
The verdict
NCT00715624, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 496 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 basal insulin 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 basal insulin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24. The secondary objectives are to assess the effects of lixisenatide when added to basal insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
- DRUG Basal Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00715624
The ClinicalTrials.gov registry entry for NCT00715624 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 496 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.
NCT00715624 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00715624 about?
NCT00715624 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 Basal Insulin". 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 basal insulin 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 NCT00715624?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 496 participants. The study started on 2008-07. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00715624?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE), Basal Insulin (DRUG).
Who is sponsoring clinical trial NCT00715624?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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