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NCT00384085 · ClinicalTrials.gov registry record · Phase 4
Insulin Glargine "All to Target" Trial
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 588
- Enrollment target
NCT00384085: Completed Phase 4 study, sponsored by Sanofi.
NCT00384085 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 588 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00384085, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 588 participants
- Enrollment target
Study Summary
The primary objectives were: * To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60 * To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c
Primary Outcome
Responders defined as patients who achieved an HbA1c value \<7.0% versus nonresponders. Patients who did not achieve an HbA1c value \<7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.
Interventions
- DRUG Insulin Glargine
- DRUG Insulin Glulisine
- DRUG Premixed Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 588 participants |
| Start Date | 2006-05 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT00384085 record still lists
NCT00384085 is an interventional study that assigns participants to a tested intervention. The registered 588 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 (14% higher).
The record links to 0 conditions, and to 3 interventions - of which Insulin Glargine is the first listed.
NCT00384085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00384085 about?
NCT00384085 is a clinical study titled "Insulin Glargine "All to Target" Trial". The primary objectives were: * To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60 ...
What is the current status of trial NCT00384085?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 588 participants. The study started on 2006-05. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00384085?
The interventions under investigation include: Insulin Glargine (DRUG), Insulin Glulisine (DRUG), Premixed Insulin (DRUG).
Who is sponsoring clinical trial NCT00384085?
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 NCT00384085's enrollment target sits among peer trials
588 148th of 2000 higher than 1,853 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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