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NCT01117350 · ClinicalTrials.gov registry record · Phase 4
Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 978
- Enrollment target
NCT01117350: Completed Phase 4 study, sponsored by Sanofi.
NCT01117350 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 978 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01117350, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 978 participants
- Enrollment target
Study Summary
Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) \< 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the comparative period (24 weeks): \>To assess the effect of insulin glargine in comparison with liraglutide on: * HbA1c level * Percentage of patients whose HbA1c has decreased but remains \>= 7% at the end of the comparative period * Percentage of patients whose HbA1c has increased at the end of the comparative period * Fasting Plasma Glucose (FPG) * 7-point Plasma Glucose (PG) profiles * Hypoglycemia occurrence * Body weight * Adverse events Objectives of the extension period (24 weeks): \>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on: * HbA1c level * FPG * 7-point PG profiles * Hypoglycemia occurrence * Body weight * Adverse events
Primary Outcome
The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward \[LOCF\] value).
Interventions
- DRUG Metformin
- DRUG Liraglutide
- DRUG Insulin glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 978 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 4 |
What the finished NCT01117350 record still lists
NCT01117350 is an interventional study that assigns participants to a tested intervention. The registered 978 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% higher).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT01117350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01117350 about?
NCT01117350 is a clinical study titled "Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure". Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) \< 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secon...
What is the current status of trial NCT01117350?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 978 participants. The study started on 2010-07. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01117350?
The interventions under investigation include: Metformin (DRUG), Liraglutide (DRUG), Insulin glargine (DRUG).
Who is sponsoring clinical trial NCT01117350?
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 NCT01117350's enrollment target sits among peer trials
978 75th of 2000 higher than 1,926 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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