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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067951
• Other study ID #: 712753/004
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2003
• Last updated: March 19, 2018
• Start date: October 17, 2003
• Est. completion date: November 30, 2004

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: November 30, 2004
• Est. primary completion date: November 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• rosiglitazone/metformin

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	Caulfield	Victoria
Australia	GSK Investigational Site	Fremantle	Western Australia
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	North Adelaide	South Australia
Australia	GSK Investigational Site	Perth	Western Australia
Australia	GSK Investigational Site	St Leonards	New South Wales
Australia	GSK Investigational Site	Wollongong	New South Wales
Australia	GSK Investigational Site	Woolloongabba	Queensland
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Coquitlam	British Columbia
Canada	GSK Investigational Site	Courtice	Ontario
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Langley	British Columbia
Canada	GSK Investigational Site	Laval	Quebec
Canada	GSK Investigational Site	Moncton	New Brunswick
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	North Bay	Ontario
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Peterborough	Ontario
Canada	GSK Investigational Site	Peterborough	Ontario
Canada	GSK Investigational Site	Plessisville	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Regina	Saskatchewan
Canada	GSK Investigational Site	Renfrew	Ontario
Canada	GSK Investigational Site	Saint Insidore De Dorchester	Quebec
Canada	GSK Investigational Site	Saint Marc Des Carrieres	Quebec
Canada	GSK Investigational Site	Sainte Jerome	Quebec
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Stoney Creek	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Korea, Republic of	GSK Investigational Site	Pusan
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Uijeongbu,
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Rotorua
New Zealand	GSK Investigational Site	Wellington
United States	GSK Investigational Site	Anniston	Alabama
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Beaumont	Texas
United States	GSK Investigational Site	Bryan	Texas
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chesterfield	Missouri
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Downingtown	Pennsylvania
United States	GSK Investigational Site	Encinitas	California
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fayetteville	Georgia
United States	GSK Investigational Site	Fullerton	California
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Kingston	New York
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Los Banos	California
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Midland	Texas
United States	GSK Investigational Site	Mission Viejo	California
United States	GSK Investigational Site	Mogadore	Ohio
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newburgh	Indiana
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Saint Cloud	Florida
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Warminster	Pennsylvania
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	West Chester	Pennsylvania
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.
Secondary	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.

External Links

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