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
  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:


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:
    Drug: Rosiglitazone
    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):
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 April 17, 2014