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NCT01517412 · ClinicalTrials.gov registry record · Phase 3
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
NCT01517412: Completed Phase 3 study, sponsored by Sanofi.
NCT01517412 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 451 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01517412, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 451 participants
- Enrollment target
Study Summary
Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: * To assess the effect of the 2 lixisenatide regimens on: * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24 * Fasting Plasma Glucose (FPG) * 7-point Self-Monitored Plasma Glucose (SMPG) profiles * Body weight * To assess the safety and tolerability of the 2 lixisenatide regimens
Primary Outcome
Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Interventions
- DRUG Metformin
- DRUG Lixisenatide (AVE0010)
- DEVICE Self-injector pen device (OptiClik®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT01517412 record still lists
NCT01517412 is an interventional study that assigns participants to a tested intervention. The registered 451 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 (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT01517412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01517412 about?
NCT01517412 is a clinical study titled "Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin". Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: * To assess the effect of the 2 lixisenatide regimens on: * The percentage of participants who reached the target of HbA1c ...
What is the current status of trial NCT01517412?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2012-02. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01517412?
The interventions under investigation include: Metformin (DRUG), Lixisenatide (AVE0010) (DRUG), Self-injector pen device (OptiClik®) (DEVICE).
Who is sponsoring clinical trial NCT01517412?
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 NCT01517412's enrollment target sits among peer trials
451 836th of 2000 higher than 1,164 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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