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NCT00449605 · ClinicalTrials.gov registry record · Phase 3

A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes

A Phase 3 study, sponsored by Sanofi.

Terminated
Registry status
Phase 3
Development phase
508
Enrollment target

NCT00449605 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 508 participants.

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The verdict

NCT00449605, a Phase 3 study, was terminated before completion, sponsored by Sanofi.

TERMINATED
Registry status
Phase 3
Development phase
508 participants
Enrollment target

Study Summary

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months. The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

Interventions

  • DRUG Metformin
  • DRUG Glimepiride
  • DRUG Rimonabant

Trial Details

FieldValue
Enrollment Target 508 participants
Start Date 2007-03
Est. Completion 2009-03
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00449605

The ClinicalTrials.gov registry entry for NCT00449605 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 508 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 Metformin is the first listed.

NCT00449605 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00449605 about?

NCT00449605 is a clinical study titled "A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes". The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose...

What is the current status of trial NCT00449605?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 508 participants. The study started on 2007-03. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00449605?

The interventions under investigation include: Metformin (DRUG), Glimepiride (DRUG), Rimonabant (DRUG).

Who is sponsoring clinical trial NCT00449605?

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.