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NCT01768559 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 894
- Enrollment target
NCT01768559: Completed Phase 3 study, sponsored by Sanofi.
NCT01768559 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 894 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01768559, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 894 participants
- Enrollment target
Study Summary
Primary Objective: \- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: \- To compare the treatments/regimens on: * The percentage of participants reaching the target of HbA1c \<7% or ≤6.5%, * Body weight, * Self-Monitored Glucose profiles, * Fasting Plasma Glucose (FPG), * Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants), * Daily doses of insulins, * Safety and tolerability.
Primary Outcome
Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment 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 Lixisenatide (AVE0010)
- DRUG Insulin glulisine QD
- DRUG Insulin glulisine TID
- DRUG Insulin Glargine (Mandatory background drug)
- DRUG Metformin (Background drug)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 894 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01768559 record still lists
NCT01768559 is an interventional study that assigns participants to a tested intervention. The registered 894 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 (16% higher).
The record links to 0 conditions, and to 5 interventions - of which Lixisenatide (AVE0010) is the first listed.
NCT01768559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01768559 about?
NCT01768559 is a clinical study titled "Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients". Primary Objective: \- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: \- To compare the treatme...
What is the current status of trial NCT01768559?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 894 participants. The study started on 2013-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01768559?
The interventions under investigation include: Lixisenatide (AVE0010) (DRUG), Insulin glulisine QD (DRUG), Insulin glulisine TID (DRUG), Insulin Glargine (Mandatory background drug) (DRUG), Metformin (Background drug) (DRUG).
Who is sponsoring clinical trial NCT01768559?
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 NCT01768559's enrollment target sits among peer trials
894 363rd of 2000 higher than 1,638 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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