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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 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 978 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01117350
The ClinicalTrials.gov registry entry for NCT01117350 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 978 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 Metformin is the first listed.
NCT01117350 reports 0 study locations.
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.
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