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NCT01658579 · ClinicalTrials.gov registry record · Phase 2
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT01658579: Completed Phase 2 study, sponsored by Sanofi.
NCT01658579 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01658579, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
Primary Objective: * To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: * To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening * To compare the incidence and frequency of hypoglycemic episodes * To assess the safety and tolerability of the new formulation of insulin glargine
Primary Outcome
Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.
Interventions
- DRUG HOE901-U300 (new formulation of insulin glargine)
- DRUG Lantus (insulin glargine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01658579 record still lists
NCT01658579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which HOE901-U300 (new formulation of insulin glargine) is the first listed.
NCT01658579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01658579 about?
NCT01658579 is a clinical study titled "Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin". Primary Objective: * To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: * To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening...
What is the current status of trial NCT01658579?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2012-08. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01658579?
The interventions under investigation include: HOE901-U300 (new formulation of insulin glargine) (DRUG), Lantus (insulin glargine) (DRUG).
Who is sponsoring clinical trial NCT01658579?
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 NCT01658579's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 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
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