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NCT01499095 · ClinicalTrials.gov registry record · Phase 3
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 811
- Enrollment target
NCT01499095: Completed Phase 3 study, sponsored by Sanofi.
NCT01499095 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 811 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01499095, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 811 participants
- Enrollment target
Study Summary
Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia
Primary Outcome
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Interventions
- DRUG Lantus (Insulin glargine)
- DRUG HOE901-U300 (new formulation of insulin glargine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 811 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT01499095 record still lists
NCT01499095 is an interventional study that assigns participants to a tested intervention. The registered 811 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Lantus (Insulin glargine) is the first listed.
NCT01499095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01499095 about?
NCT01499095 is a clinical study titled "Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy". Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: * To compare the efficacy of ins...
What is the current status of trial NCT01499095?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 811 participants. The study started on 2011-12. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01499095?
The interventions under investigation include: Lantus (Insulin glargine) (DRUG), HOE901-U300 (new formulation of insulin glargine) (DRUG).
Who is sponsoring clinical trial NCT01499095?
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 NCT01499095's enrollment target sits among peer trials
811 408th of 2000 higher than 1,592 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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