A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics - Tabular View

Tracking Information

First Received Date ^ICMJE

September 3, 2003

Last Updated Date

August 27, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.

Original Primary Outcome Measures ^ICMJE

Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.

Change History

Complete list of historical versions of study NCT00067951 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.

Original Secondary Outcome Measures ^ICMJE

Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids.
Change in weight, vital signs, clinical laboratory tests, and adverse experiences.

Descriptive Information

Brief Title ^ICMJE

A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

Official Title ^ICMJE

An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects With Type 2 Diabetes Mellitus

Brief Summary

The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-Insulin-Dependent Diabetes Mellitus

Intervention ^ICMJE

Drug: rosiglitazone/metformin

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 ^ICMJE

Completed

Enrollment ^ICMJE

190

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Laboratory result for HbA1c >11% or FPG >270mg/dL
Clinical diagnosis of Type II diabetes
Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.

Exclusion Criteria:

Women who are pregnant

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Korea, Republic of, New Zealand

Administrative Information

NCT ID ^ICMJE

NCT00067951

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

712753/004

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP