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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 281 participants.

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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

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00135057

The ClinicalTrials.gov registry entry for NCT00135057 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 281 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 2 interventions - of which insulin glargine is the first listed.

NCT00135057 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.