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

NCT00297063 | Completed Phase 3

• 1 other identifier: AVD104742
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

rosiglitazone; vandia; Type 2 diabetes mellitus; diabetes;

Outcome Measures

Primary Outcomes (1)

• HbA1c change from baseline at Week 28.

  28 Weeks

Secondary Outcomes (1)

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

  28 Weeks

Interventions

Rosiglitazone DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus.
• Managed by diet therapy.
• Must have adequate blood, liver and kidney function.

You may not qualify if:

• Serious cardiovascular disease or serious hepatic disease.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Fukuoka, 819-0168, Japan

Location

GSK Investigational Site

Fukushima, 962-0856, Japan

Location

GSK Investigational Site

Hokkaido, 051-0005, Japan

Location

GSK Investigational Site

Ibaraki, 311-0113, Japan

Location

GSK Investigational Site

Kanagawa, 224-0024, Japan

Location

GSK Investigational Site

Kyoto, 615-0035, Japan

Location

GSK Investigational Site

Nagano, 399-0006, Japan

Location

GSK Investigational Site

Osaka, 577-0803, Japan

Location

GSK Investigational Site

Saitama, 349-1105, Japan

Location

GSK Investigational Site

Shizuoka, 424-0855, Japan

Location

GSK Investigational Site

Tokyo, 125-0054, Japan

Location

GSK Investigational Site

Tokyo, 130-0004, Japan

Location

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

GSK Investigational Site

Location

Related Publications (2)

• Kikuchi M, Kaku K, Odawara M, Momomura S, Ishii R. Efficacy and tolerability of rosiglitazone and pioglitazone in drug-naive 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.

  PMID: 22587483 BACKGROUND

• 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.

  PMID: 21562320 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 27, 2006
• Study Start: January 11, 2006
• Primary Completion: May 31, 2007
• Study Completion: May 31, 2007
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (13)