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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 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 588 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00384085
The ClinicalTrials.gov registry entry for NCT00384085 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 588 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 Insulin Glargine is the first listed.
NCT00384085 reports 0 study locations.
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.
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