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

NCT00499707 | Completed Phase 3

• 1 other identifier: 712753/007
• Study Type: interventional
• Target: 453
• Locations: 7 countries
• Sites: 102

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

HbA1c; Drug-naive; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in hemoglobin A1c (HbA1c) at week 32.

  at 32 week

Secondary Outcomes (1)

• 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

Interventions

rosiglitazone maleate/metformin hydrochloride DRUG

rosiglitazone maleate/metformin hydrochloride

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (102)

GSK Investigational Site

Anniston, Alabama, 36207, United States

Location

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85014, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85050, United States

Location

GSK Investigational Site

Tucson, Arizona, 85745, United States

Location

GSK Investigational Site

Encinitas, California, 92024, United States

Location

GSK Investigational Site

Fullerton, California, 92835, United States

Location

GSK Investigational Site

Los Banos, California, 93635, United States

Location

GSK Investigational Site

Mission Viejo, California, 92691, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32204, United States

Location

GSK Investigational Site

Melbourne, Florida, 32901, United States

Location

GSK Investigational Site

Miami, Florida, 33156, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Saint Cloud, Florida, 34769, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Fayetteville, Georgia, 30214, United States

Location

GSK Investigational Site

Woodstock, Georgia, 30189, United States

Location

GSK Investigational Site

Chicago, Illinois, 60607, United States

Location

GSK Investigational Site

Evansville, Indiana, 47713, United States

Location

GSK Investigational Site

Newburgh, Indiana, 47630, United States

Location

GSK Investigational Site

Slidell, Louisiana, 70461, United States

Location

GSK Investigational Site

Jackson, Mississippi, 39202, United States

Location

GSK Investigational Site

Chesterfield, Missouri, 63017, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

St Louis, Missouri, 63376, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89103, United States

Location

GSK Investigational Site

Kingston, New York, 12401, United States

Location

GSK Investigational Site

New York, New York, 10024, United States

Location

GSK Investigational Site

New York, New York, 10029, United States

Location

GSK Investigational Site

New York, New York, 10032, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28210, United States

Location

GSK Investigational Site

Mogadore, Ohio, 44260, United States

Location

GSK Investigational Site

Downingtown, Pennsylvania, 19335, United States

Location

GSK Investigational Site

Warminster, Pennsylvania, 18974, United States

Location

GSK Investigational Site

West Chester, Pennsylvania, 19382, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Johnson City, Tennessee, 37601, United States

Location

GSK Investigational Site

Arlington, Texas, 76017, United States

Location

GSK Investigational Site

Beaumont, Texas, 77701, United States

Location

GSK Investigational Site

Bryan, Texas, 77802, United States

Location

GSK Investigational Site

Dallas, Texas, 75230, United States

Location

GSK Investigational Site

Midland, Texas, 79705, United States

Location

GSK Investigational Site

San Antonio, Texas, 78221, United States

Location

GSK Investigational Site

San Antonio, Texas, 78237, United States

Location

GSK Investigational Site

Seattle, Washington, 98108, United States

Location

GSK Investigational Site

Spokane, Washington, 99207, United States

Location

GSK Investigational Site

Wenatchee, Washington, 98801, United States

Location

GSK Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

GSK Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

GSK Investigational Site

Wollongong, New South Wales, 2500, Australia

Location

GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

Location

GSK Investigational Site

Woolloongabba, Queensland, 4102, Australia

Location

GSK Investigational Site

North Adelaide, South Australia, 5006, Australia

Location

GSK Investigational Site

Caulfield, Victoria, 3162, Australia

Location

GSK Investigational Site

Fremantle, Western Australia, 6959, Australia

Location

GSK Investigational Site

Perth, Western Australia, 6000, Australia

Location

GSK Investigational Site

Recife, Pernambuco, 50100-130, Brazil

Location

GSK Investigational Site

São Paulo, 04020-041, Brazil

Location

GSK Investigational Site

Calgary, Alberta, T3E 0C5, Canada

Location

GSK Investigational Site

Coquitlam, British Columbia, V3K 3V9, Canada

Location

GSK Investigational Site

Langley, British Columbia, V3A 4H9, Canada

Location

GSK Investigational Site

Moncton, New Brunswick, E1G 1A7, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3K 5R3, Canada

Location

GSK Investigational Site

Brampton, Ontario, L6T 3T1, Canada

Location

GSK Investigational Site

Burlington, Ontario, L7M 4Y1, Canada

Location

GSK Investigational Site

Courtice, Ontario, L1E 3C3, Canada

Location

GSK Investigational Site

Kitchener, Ontario, N2C 2N9, Canada

Location

GSK Investigational Site

North Bay, Ontario, P1B 2H3, Canada

Location

GSK Investigational Site

Oshawa, Ontario, L1H 1C2, Canada

Location

GSK Investigational Site

Peterborough, Ontario, K9H 5G1, Canada

Location

GSK Investigational Site

Peterborough, Ontario, K9J 7B3, Canada

Location

GSK Investigational Site

Renfrew, Ontario, K7V 1P6, Canada

Location

GSK Investigational Site

Stoney Creek, Ontario, L8G 2V6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3J 1N2, Canada

Location

GSK Investigational Site

Laval, Quebec, H7T 2P5, Canada

Location

GSK Investigational Site

Montreal, Quebec, H1V 1X4, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3S 2W1, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4N 2W2, Canada

Location

GSK Investigational Site

Plessisville, Quebec, G6L 3J1, Canada

Location

GSK Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

GSK Investigational Site

Saint Insidore de Dorchester, Quebec, G0S 2S0, Canada

Location

GSK Investigational Site

Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada

Location

GSK Investigational Site

Sainte Jerome, Quebec, J7Z 5T3, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

GSK Investigational Site

Regina, Saskatchewan, S4S 0A2, Canada

Location

GSK Investigational Site

Regina, Saskatchewan, S4S 3R8, Canada

Location

GSK Investigational Site

Saskatoon, Saskatchewan, S7K 0M5, Canada

Location

GSK Investigational Site

Tijuana, Baja California Norte, 22320, Mexico

Location

GSK Investigational Site

Guadalajara, Jalisco, 44340, Mexico

Location

GSK Investigational Site

Monterrey, Nuevo León, 64570, Mexico

Location

GSK Investigational Site

Durango, 3400, Mexico

Location

GSK Investigational Site

Mexico City, 11850, Mexico

Location

GSK Investigational Site

Mexico City, 14050, Mexico

Location

GSK Investigational Site

Auckland, 1311, New Zealand

Location

GSK Investigational Site

Auckland, 1701, New Zealand

Location

GSK Investigational Site

Christchurch, 8001, New Zealand

Location

GSK Investigational Site

Rotorua, 3201, New Zealand

Location

GSK Investigational Site

Wellington, 6035, New Zealand

Location

GSK Investigational Site

Pusan, 602-739, South Korea

Location

GSK Investigational Site

Seoul, 139-872, South Korea

Location

GSK Investigational Site

Uijeongbu-si, 480-821, South Korea

Location

Related 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 Study of Diabetes, 10-15 September 2005, Athens, Greece.

  RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Rosiglitazone; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: October 8, 2003
• Primary Completion: December 1, 2004
• Study Completion: December 16, 2004
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

KR (3); BR (2); CA (29); US (48); AU (9); ME (6); NZ (5)