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NCT00135096 · ClinicalTrials.gov registry record · Phase 3
Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 345
- Enrollment target
NCT00135096: Completed Phase 3 study, sponsored by Sanofi.
NCT00135096 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 345 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135096, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 345 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.
Interventions
- DRUG insulin glargine
- DRUG insulin glulisine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2004-08 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
What the finished NCT00135096 record still lists
NCT00135096 is an interventional study that assigns participants to a tested intervention. The registered 345 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 (55% lower).
The record links to 0 conditions, and to 2 interventions - of which insulin glargine is the first listed.
NCT00135096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00135096 about?
NCT00135096 is a clinical study titled "Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin". The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.
What is the current status of trial NCT00135096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2004-08. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00135096?
The interventions under investigation include: insulin glargine (DRUG), insulin glulisine (DRUG).
Who is sponsoring clinical trial NCT00135096?
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 NCT00135096's enrollment target sits among peer trials
345 1050th of 2000 higher than 951 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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