Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Sanofi.
NCT01476475 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 323 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
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 till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP).
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 |
What the finished NCT01476475 record still lists
NCT01476475 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 3 interventions - of which Insulin glargine is the first listed.
NCT01476475 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01476475's enrollment target sits among peer trials
323 150th of 2000 higher than 1,851 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04164173 · 324 participants · NA
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
- NCT04708054 · 324 participants · Phase 2
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
- NCT05261399 · 324 participants · Phase 3
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
- NCT05353322 · 324 participants · NA
Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia