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NCT01476475 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 323
- Enrollment target
NCT01476475 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 323 participants.
The verdict
NCT01476475, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 323 participants
- Enrollment target
Study Summary
Primary Objective: * The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin. Secondary Objectives: * To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on: * Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test; * Percentage of participants reaching HbA1c \<7% or ≤6.5%; * 7-point Self-Monitored Plasma Glucose (SMPG) profile; * Body weight; * Insulin glargine dose * Fasting Plasma Glucose (FPG); * Percentage of participants requiring rescue therapy during the 24-week open label treatment period; * To assess safety and tolerability of insulin glargine/lixisenatide FRC.
Interventions
- DRUG Insulin glargine
- DRUG Metformin (Background drug)
- DRUG Insulin glargine /lixisenatide Fixed Ratio Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01476475
The ClinicalTrials.gov registry entry for NCT01476475 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 323 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 3 interventions - of which Insulin glargine is the first listed.
NCT01476475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01476475 about?
NCT01476475 is a clinical study titled "Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients". Primary Objective: * The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin. Se...
What is the current status of trial NCT01476475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 323 participants. The study started on 2011-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01476475?
The interventions under investigation include: Insulin glargine (DRUG), Metformin (Background drug) (DRUG), Insulin glargine /lixisenatide Fixed Ratio Combination (DRUG).
Who is sponsoring clinical trial NCT01476475?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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