A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

Verified by: GlaxoSmithKline, October 2010
First Received: August 31, 2007 | Last Updated: October 1, 2010 | Phase: Phase 3 | Start Date: November 2005
Overall Status: Completed | Estimated Enrollment: 70
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This study is designed to evaluate the safety of BRL49653C administrated for 52...

Brief Summary

Official Title: “Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-”

This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2007

Intervention(s) in this Clinical Trial

  • Drug: rosiglitazone

Outcome Measures for this Clinical Trial

Primary Measures

  • The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated.
    • Time Frame: 52 Weeks

Secondary Measures

  • The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated.
    • Time Frame: 52 Weeks

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates 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, MD 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/NCT00523913

Study ID Number: AVD105720

ClinicalTrials.gov Identifier: NCT00523913

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00523913