A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: Rosiglitazone (BRL49653C) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical trials, Mr, Study Director, Affiliation: GlaxoSmithKline
Summary
This study was designed to compare the efficacy and safety of BRL49653C versus placebo with
concomitant use of sulfonyl urea (SU).
Clinical Details
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 -
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in HbA1c after 16 weeks of treatment in rosiglitazone group and placebo group
Secondary outcome: 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
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Clinical Trials Call Center, Chiba 278, Japan
GSK Clinical Trials Call Center, Kanagawa 242, Japan
GSK Clinical Trials Call Center, Hiroshima 721, Japan
GSK Clinical Trials Call Center, Fukuoka 819, Japan
GSK Clinical Trials Call Center, Miyazaki 880, Japan
GSK Clinical Trials Call Center, Hiroshima 737, Japan
GSK Clinical Trials Call Center, Tokyo 100, Japan
GSK Clinical Trials Call Center, Aichi 457, Japan
GSK Clinical Trials Call Center, Saitama 339, Japan
GSK Clinical Trials Call Center, Kanagawa 212, Japan
GSK Clinical Trials Call Center, Oita 870, Japan
GSK Clinical Trials Call Center, Fukuoka 810, Japan
GSK Clinical Trials Call Center, Kanagawa 259, Japan
GSK Clinical Trials Call Center, Kanagawa 221, Japan
GSK Clinical Trials Call Center, Okayama 710, Japan
GSK Clinical Trials Call Center, Fukuoka 811, Japan
GSK Clinical Trials Call Center, Kumamoto 862, Japan
Additional Information
Starting date: April 2006
Last updated: August 10, 2007
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