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NCT00135057 · ClinicalTrials.gov registry record · Phase 3
Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 281
- Enrollment target
NCT00135057: Completed Phase 3 study, sponsored by Sanofi.
NCT00135057 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 281 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135057, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 281 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal insulin in both arms of the study.
Interventions
- DRUG insulin glargine
- DRUG insulin glulisine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2004-04 |
| Est. Completion | 2005-08 |
| Phase | Phase 3 |
What the finished NCT00135057 record still lists
NCT00135057 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which insulin glargine is the first listed.
NCT00135057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00135057 about?
NCT00135057 is a clinical study titled "Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin". The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus i...
What is the current status of trial NCT00135057?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 281 participants. The study started on 2004-04. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00135057?
The interventions under investigation include: insulin glargine (DRUG), insulin glulisine (DRUG).
Who is sponsoring clinical trial NCT00135057?
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 NCT00135057's enrollment target sits among peer trials
281 1194th of 2000 higher than 806 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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