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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 894 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01768559
The ClinicalTrials.gov registry entry for NCT01768559 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 894 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 Lixisenatide (AVE0010) is the first listed.
NCT01768559 reports 0 study locations.
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.
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