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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rosiglitazone (BRL49653C)

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
    

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

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical trials, Mr Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

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