Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499707
• Other study ID #: 712753/007
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2007
• Last updated: March 19, 2018
• Start date: October 8, 2003
• Est. completion date: December 16, 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 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: December 16, 2004
• Est. primary completion date: December 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 to 70 years of age

• Clinical diagnosis of type 2 diabetes

• HbA1c >7.5% to 11%

• FPG <270mg/dL (15mmol)

• Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening

Exclusion Criteria:

• Clinically significant renal or hepatic disease

• Presence of anemia

• Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy

• Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment

• Chronic disease requiring intermittent or chronic treatment with corticosteroids

• Any female lactating, pregnant, or planning to become pregnant

• History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione

• Presence of acute or chronic metabolic acidosis

• History of diabetic ketoacidosis

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• rosiglitazone maleate/metformin hydrochloride
rosiglitazone maleate/metformin hydrochloride

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
Brazil	GSK Investigational Site	Recife	Pernambuco
Brazil	GSK Investigational Site	São Paulo
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	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,
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico, D.F.
Mexico	GSK Investigational Site	Mexico, D.F.
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Mexico	GSK Investigational Site	Tijuana	Baja California Norte
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	Beaumont	Texas
United States	GSK Investigational Site	Bristol	Tennessee
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	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,  Brazil,  Canada,  Korea, Republic of,  Mexico,  New Zealand, 

References & Publications (1)

Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin A1c (HbA1c) at week 32.		at 32 week
Secondary	Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks		at 32 weeksInvalid value