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A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

NCT ID: NCT00432679

Last Updated: 2022-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-24

Study Completion Date

2007-03-28

Brief Summary

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This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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rosiglitazone Avandia type 2 diabetes mellitus diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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arm 1

study drug

Group Type EXPERIMENTAL

Rosiglitazone (BRL49653C)

Intervention Type DRUG

study drug

Interventions

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Rosiglitazone (BRL49653C)

study drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion Criteria

* Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Kumamoto, , Japan

Site Status

GSK Investigational Site

Ōita, , Japan

Site Status

GSK Investigational Site

, ,

Site Status

Countries

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Japan

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Individual Participant Data Set

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Document Type: Clinical Study Report

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Document Type: Annotated Case Report Form

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Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form

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Document Type: Study Protocol

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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AVD105248

Identifier Type: -

Identifier Source: org_study_id