BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus

Intervention: Rosiglitazone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, Study Director, Affiliation: GlaxoSmithKline

This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.

Official title: Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo -

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

Primary outcome: HbA1c change from baseline at Week 28.

Secondary outcome: Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group.

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Type 2 diabetes mellitus.

- Managed by diet therapy.

- Must have adequate blood, liver and kidney function.

Exclusion criteria:

- Serious cardiovascular disease or serious hepatic disease.

GSK Clinical Trials Call Center, Nagano 399, Japan

GSK Clinical Trials Call Center, Miyagi 980, Japan

GSK Clinical Trials Call Center, Saitama 349, Japan

GSK Clinical Trials Call Center, Kyoto 616, Japan

GSK Clinical Trials Call Center, Ibaragi 311, Japan

GSK Clinical Trials Call Center, Hyogo 651, Japan

GSK Clinical Trials Call Center, Hyogo 664, Japan

GSK Clinical Trials Call Center, Fukushima 964, Japan

GSK Clinical Trials Call Center, Tokyo 160, Japan

GSK Clinical Trials Call Center, Osaka 565, Japan

GSK Clinical Trials Call Center, Tochigi 329, Japan

GSK Clinical Trials Call Center, Kanagawa 224, Japan

GSK Clinical Trials Call Center, Fukushima 962, Japan

GSK Clinical Trials Call Center, Gunma 379, Japan

GSK Clinical Trials Call Center, Gunma 371, Japan

GSK Clinical Trials Call Center, Tokyo 125, Japan

GSK Clinical Trials Call Center, Chiba 292, Japan

GSK Clinical Trials Call Center, Tokyo 192, Japan

GSK Clinical Trials Call Center, Nagano 392, Japan

GSK Clinical Trials Call Center, Saitama 354, Japan

GSK Clinical Trials Call Center, Hokkaido 061, Japan

GSK Clinical Trials Call Center, Tokyo 105, Japan

GSK Clinical Trials Call Center, Kyoto 615, Japan

GSK Clinical Trials Call Center, Tokyo 162, Japan

GSK Clinical Trials Call Center, Saitama 346, Japan

GSK Clinical Trials Call Center, Osaka 577, Japan

GSK Clinical Trials Call Center, Fukuoka 812, Japan

GSK Clinical Trials Call Center, Fukuoka 805, Japan

GSK Clinical Trials Call Center, Fukuoka 819, Japan

GSK Clinical Trials Call Center, Fukuoka 802, Japan

GSK Clinical Trials Call Center, Tokyo 141, Japan

GSK Clinical Trials Call Center, Osaka 570, Japan

GSK Clinical Trials Call Center, Shizuoka 424, Japan

GSK Clinical Trials Call Center, Tokyo 103, Japan

GSK Clinical Trials Call Center, Osaka 557, Japan

GSK Clinical Trials Call Center, Tokyo 101, Japan

Starting date: December 2005
Last updated: August 10, 2007