Clinical trial NCT00499707: Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: HbA1c
Drug-naive
type 2 diabetes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in hemoglobin A1c (HbA1c) at week 32.
timeFrame: at 32 week
Secondary outcomes:
measure: 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
timeFrame: at 32 weeksInvalid value
Other outcomes:
Locations:
city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Encinitas
country: United States
facility: GSK Investigational Site
state: California
city: Fullerton
country: United States
facility: GSK Investigational Site
state: California
city: Los Banos
country: United States
facility: GSK Investigational Site
state: California
city: Mission Viejo
country: United States
facility: GSK Investigational Site
state: California
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Cloud
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Newburgh
country: United States
facility: GSK Investigational Site
state: Indiana
city: Slidell
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Jackson
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Chesterfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Kingston
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Mogadore
country: United States
facility: GSK Investigational Site
state: Ohio
city: Downingtown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Warminster
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: West Chester
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: GSK Investigational Site
state: Texas
city: Beaumont
country: United States
facility: GSK Investigational Site
state: Texas
city: Bryan
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Midland
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Camperdown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Woolloongabba
country: Australia
facility: GSK Investigational Site
state: Queensland
city: North Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Caulfield
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Perth
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Recife
country: Brazil
facility: GSK Investigational Site
state: Pernambuco
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Langley
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Moncton
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Burlington
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Courtice
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Renfrew
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Stoney Creek
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Laval
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Plessisville
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Insidore De Dorchester
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Marc Des Carrieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte Jerome
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Regina
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Regina
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: GSK Investigational Site
state: Saskatchewan
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Uijeongbu,
country: Korea, Republic of
facility: GSK Investigational Site
city: Tijuana
country: Mexico
facility: GSK Investigational Site
state: Baja California Norte
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Rotorua
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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 Study of Diabetes, 10-15 September 2005, Athens, Greece.