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NCT00297063 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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 -

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00297063
Other study ID # AVD104742
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 11, 2006
Est. completion date May 31, 2007

Study information
Verified date November 2022
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date May 31, 2007
Est. primary completion date May 31, 2007
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rosiglitazone

Locations
Country Name City State
GSK Investigational Site
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukushima
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Ibaraki
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Kyoto
Japan GSK Investigational Site Nagano
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Saitama
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Kikuchi M, Kaku K, Odawara M, Momomura S, Ishii R. Efficacy and tolerability of rosiglitazone and pioglitazone in drug-naïve Japanese patients with type 2 diabetes mellitus: a double-blind, 28 weeks' treatment, comparative study. Curr Med Res Opin. 2012 Jun;28(6):1007-16. doi: 10.1185/03007995.2012.694361. Epub 2012 Jun 6. — View Citation

MacDonald MR, Petrie MC, Home PD, Komajda M, Jones NP, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock SJ, Curtis PS, McMurray JJ. Incidence and prevalence of unrecognized myocardial infarction in people with diabetes: a substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. Diabetes Care. 2011 Jun;34(6):1394-6. doi: 10.2337/dc10-2398. Epub 2011 May 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c change from baseline at Week 28. 28 Weeks
Secondary Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group. 28 Weeks
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