A Study Of BRL49653C For The Treatment Of Type 2 Diabetes
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 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: Sec.1, MDC-J CVM
Summary
This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks
Clinical Details
Official title: Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-Term Study of Rosiglitazone Maleate-
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated.
Secondary outcome: The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Clinical Trials Call Center, Tokyo 105, Japan
GSK Clinical Trials Call Center, Tokyo 160, Japan
GSK Clinical Trials Call Center, Osaka 565, Japan
Additional Information
Starting date: November 2005
Last updated: August 31, 2007
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