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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00297063
First received: February 24, 2006
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.

Condition Intervention Phase
Diabetes Mellitus, Type 2
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
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
GSK Investigational Site
Ibaraki, Japan, 311-0113
GSK Investigational Site
Kanagawa, Japan, 224-0024
GSK Investigational Site
Tokyo, Japan, 125-0054
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AVD104742
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AVD104742
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AVD104742
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AVD104742
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AVD104742
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AVD104742
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AVD104742
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00297063     History of Changes
Other Study ID Numbers: AVD104742 
Study First Received: February 24, 2006
Last Updated: October 27, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
rosiglitazone
vandia
Type 2 diabetes mellitus
diabetes;

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

ClinicalTrials.gov processed this record on December 07, 2016