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

November 15, 2022 updated by: GlaxoSmithKline

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 -

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • GSK Investigational Site
  • Japan
      • Fukuoka, Japan, 819-0168
        • GSK Investigational Site
      • Fukushima, Japan, 962-0856
        • GSK Investigational Site
      • Hokkaido, Japan, 051-0005
        • GSK Investigational Site
      • Ibaraki, Japan, 311-0113
        • GSK Investigational Site
      • Kanagawa, Japan, 224-0024
        • GSK Investigational Site
      • Kyoto, Japan, 615-0035
        • GSK Investigational Site
      • Nagano, Japan, 399-0006
        • GSK Investigational Site
      • Osaka, Japan, 577-0803
        • GSK Investigational Site
      • Saitama, Japan, 349-1105
        • GSK Investigational Site
      • Shizuoka, Japan, 424-0855
        • GSK Investigational Site
      • Tokyo, Japan, 160-0017
        • GSK Investigational Site
      • Tokyo, Japan, 130-0004
        • GSK Investigational Site
      • Tokyo, Japan, 125-0054
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c change from baseline at Week 28.
Time Frame: 28 Weeks
28 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
28 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2006

Primary Completion (Actual)

May 31, 2007

Study Completion (Actual)

May 31, 2007

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVD104742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Clinical Study Report
    Information identifier: AVD104742
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: AVD104742
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: AVD104742
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: AVD104742
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: AVD104742
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: AVD104742
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: AVD104742
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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