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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00297063

First received: February 24, 2006

Last updated: October 1, 2010

Last verified: October 2010

History of Changes

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 3

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:

HbA1c change from baseline at Week 28. [ Time Frame: 28 Weeks ]

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

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

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 by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2012 Jun 6.

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 June 18, 2013

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