A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics
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
1 other identifier
interventional
190
5 countries
94
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Oct 2003
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2003
CompletedFirst Posted
Study publicly available on registry
September 5, 2003
CompletedStudy Start
First participant enrolled
October 17, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2004
CompletedMarch 21, 2018
March 1, 2018
1 year
September 3, 2003
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (94)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Encinitas, California, 92024, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Los Banos, California, 93635, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Jacksonville, Florida, 32204, United States
GSK Investigational Site
Melbourne, Florida, 32901, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Saint Cloud, Florida, 34769, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Fayetteville, Georgia, 30214, United States
GSK Investigational Site
Woodstock, Georgia, 30189, United States
GSK Investigational Site
Chicago, Illinois, 60607, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Newburgh, Indiana, 47630, United States
GSK Investigational Site
Slidell, Louisiana, 70461, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
St Louis, Missouri, 63376, United States
GSK Investigational Site
Las Vegas, Nevada, 89103, United States
GSK Investigational Site
Kingston, New York, 12401, United States
GSK Investigational Site
New York, New York, 10024, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Charlotte, North Carolina, 28210, United States
GSK Investigational Site
Mogadore, Ohio, 44260, United States
GSK Investigational Site
Downingtown, Pennsylvania, 19335, United States
GSK Investigational Site
Warminster, Pennsylvania, 18974, United States
GSK Investigational Site
West Chester, Pennsylvania, 19382, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Arlington, Texas, 76017, United States
GSK Investigational Site
Beaumont, Texas, 77701, United States
GSK Investigational Site
Bryan, Texas, 77802, United States
GSK Investigational Site
Corpus Christi, Texas, 78411, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Midland, Texas, 79705, United States
GSK Investigational Site
San Antonio, Texas, 78221, United States
GSK Investigational Site
San Antonio, Texas, 78237, United States
GSK Investigational Site
Seattle, Washington, 98108, United States
GSK Investigational Site
Spokane, Washington, 99207, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Camperdown, New South Wales, 2050, Australia
GSK Investigational Site
St Leonards, New South Wales, 2065, Australia
GSK Investigational Site
Wollongong, New South Wales, 2500, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Woolloongabba, Queensland, 4102, Australia
GSK Investigational Site
North Adelaide, South Australia, 5006, Australia
GSK Investigational Site
Caulfield, Victoria, 3162, Australia
GSK Investigational Site
Fremantle, Western Australia, 6959, Australia
GSK Investigational Site
Perth, Western Australia, 6000, Australia
GSK Investigational Site
Calgary, Alberta, T3E 0C5, Canada
GSK Investigational Site
Coquitlam, British Columbia, V3K 3V9, Canada
GSK Investigational Site
Langley, British Columbia, V3A 4H9, Canada
GSK Investigational Site
Moncton, New Brunswick, E1G 1A7, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 5R3, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Burlington, Ontario, L7M 4Y1, Canada
GSK Investigational Site
Courtice, Ontario, L1E 3C3, Canada
GSK Investigational Site
Kitchener, Ontario, N2C 2N9, Canada
GSK Investigational Site
North Bay, Ontario, P1B 2H3, Canada
GSK Investigational Site
Oshawa, Ontario, L1H 1C2, Canada
GSK Investigational Site
Peterborough, Ontario, K9H 5G1, Canada
GSK Investigational Site
Peterborough, Ontario, K9J 7B3, Canada
GSK Investigational Site
Renfrew, Ontario, K7V 1P6, Canada
GSK Investigational Site
Stoney Creek, Ontario, L8G 2V6, Canada
GSK Investigational Site
Toronto, Ontario, M3J 1N2, Canada
GSK Investigational Site
Laval, Quebec, H7T 2P5, Canada
GSK Investigational Site
Montreal, Quebec, H1V 1X4, Canada
GSK Investigational Site
Montreal, Quebec, H3S 2W1, Canada
GSK Investigational Site
Montreal, Quebec, H4N 2W2, Canada
GSK Investigational Site
Plessisville, Quebec, G6L 3J1, Canada
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
GSK Investigational Site
Saint Insidore de Dorchester, Quebec, G0S 2S0, Canada
GSK Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada
GSK Investigational Site
Sainte Jerome, Quebec, J7Z 5T3, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1, Canada
GSK Investigational Site
Regina, Saskatchewan, S4P 3X1, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 0M5, Canada
GSK Investigational Site
Auckland, 1311, New Zealand
GSK Investigational Site
Auckland, 1701, New Zealand
GSK Investigational Site
Christchurch, 8001, New Zealand
GSK Investigational Site
Rotorua, 3201, New Zealand
GSK Investigational Site
Wellington, 6035, New Zealand
GSK Investigational Site
Pusan, 602-739, South Korea
GSK Investigational Site
Seoul, 139-872, South Korea
GSK Investigational Site
Uijeongbu-si, 480-821, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2003
First Posted
September 5, 2003
Study Start
October 17, 2003
Primary Completion
November 1, 2004
Study Completion
November 30, 2004
Last Updated
March 21, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.