BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-

Verified by: GlaxoSmithKline, October 2010
First Received: February 24, 2006 | Last Updated: October 1, 2010 | Phase: Phase 3 | Start Date: January 2006
Overall Status: Completed | Estimated Enrollment: 350
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This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo...

Brief Summary

Official Title: “Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo -”

This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

  • Drug: Rosiglitazone

Outcome Measures for this Clinical Trial

Primary Measures

  • HbA1c change from baseline at Week 28.
    • Time Frame: 28 Weeks

Secondary Measures

  • Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group.
    • Time Frame: 28 Weeks

Criteria for Participation in this Clinical Trial

Inclusion criteria:

  • Type 2 diabetes mellitus.
  • Managed by diet therapy.
  • Must have adequate blood, liver and kidney function.

Exclusion criteria:

  • Serious cardiovascular disease or serious hepatic disease.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00297063

Study ID Number: AVD104742

ClinicalTrials.gov Identifier: NCT00297063

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00297063