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

This study has been completed.

First Received on February 24, 2006. Last Updated on October 1, 2010 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00297063

Purpose

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

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus	Drug: Rosiglitazone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 -

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Secondary Outcome Measures:

Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group. [ Time Frame: 28 Weeks ]

Enrollment:	350
Study Start Date:	January 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: Rosiglitazone

Eligibility

Criteria

Inclusion criteria:

Exclusion criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297063

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00297063 History of Changes
Other Study ID Numbers:	AVD104742
Study First Received:	February 24, 2006
Last Updated:	October 1, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:

Type 2 diabetes mellitus
diabetes;
vandia
rosiglitazone

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012