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A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

rosiglitazone

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring type 2 diabetes mellitus;, diabetes;, rosiglitazone, Avandia;

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates 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.

Sites / Locations

GSK Investigational Site

Outcomes

Primary Outcome Measures

The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated.

Secondary Outcome Measures

The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated.

Full Information

NCT ID

NCT00523913

First Posted

August 31, 2007

Last Updated

October 26, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00523913

Brief Title

A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

Official Title

Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes mellitus;, diabetes;, rosiglitazone, Avandia;

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

rosiglitazone

Primary Outcome Measure Information:

Title

The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated.

Time Frame

52 Weeks

Secondary Outcome Measure Information:

Title

The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated.

Time Frame

52 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

Citation

This study has not been published in the scientific literature.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

AVD105720

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

AVD105720

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

AVD105720

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

AVD105720

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

AVD105720

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

AVD105720

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

AVD105720

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

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