Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 281 participants
Start Date 2004-04
Est. Completion 2005-08
Phase Phase 3
Sanofi

713 total trials

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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04521231 · 281 participants · Phase 1

    A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

  • NCT06190730 · 281 participants · NA

    REmote Symptom COllection to improVE postopeRative Care

  • NCT02860364 · 282 participants · NA

    Comparing Hypothermic Temperatures During Hemiarch Surgery

  • NCT04867395 · 282 participants · NA

    A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00135057, the US trial registry maintained by the National Library of Medicine. NCT00135057 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.