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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 24, 2006

Last Updated Date

October 15, 2008

Start Date ^†

January 2006

Current Primary Outcome Measures ^†

HbA1c change from baseline at Week 28. [ Time Frame: 28 Weeks ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00297063 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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 -

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Non-Insulin-Dependent Diabetes Mellitus

Intervention ^†

Drug: Rosiglitazone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

350

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00297063

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.