A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

Verified by: GlaxoSmithKline, October 2010
First Received: February 6, 2007 | Last Updated: October 1, 2010 | Phase: Phase 3 | Start Date: May 2006
Overall Status: Completed | Estimated Enrollment: 140
  • …
  • Tell a FriendPrint

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU)...

Brief Summary

Official Title: “Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With SU) - A Placebo-Controlled Double-Blind Study -”

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

  • 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: March 2007

Intervention(s) in this Clinical Trial

  • Drug: Rosiglitazone (BRL49653C)

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from baseline in HbA1c after 16 weeks of treatment in rosiglitazone group and placebo group
    • Time Frame: 16 Weeks

Secondary Measures

  • Change from baseline after 16 weeks of treatment in FPG; fasting insulin, fasting proinsulin, HOMA-IR and HOMA-; adiponectin, leptin and hs-CRP Proportion of cases with changes in HbA1c and FPG meeting specified criteria after 16 weeks of treatment
    • Time Frame: 16 Weeks

Criteria for Participation in this Clinical Trial

Inclusion criteria:

  • Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion criteria:

  • Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

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, Mr 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/NCT00432679

Study ID Number: AVD105248

ClinicalTrials.gov Identifier: NCT00432679

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00432679