Last updated: 11/04/2018 04:07:09
A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: rosiglitazone/metformin
Enrollment:
190
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
metformin, rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
October 2003 to November 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Laboratory result for HbA1c >11% or FPG >270mg/dL
- Clinical diagnosis of Type II diabetes
- Women who are pregnant
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Study Complete
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Status
Study Complete
Location
GSK Investigational Site
North Bay, Ontario, Canada, P1B 2H3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stoney Creek, Ontario, Canada, L8G 2V6
Status
Study Complete
Location
GSK Investigational Site
Encinitas, California, United States, 92024
Status
Study Complete
Location
GSK Investigational Site
Saint Insidore de Dorchester, Québec, Canada, G0S 2S0
Status
Study Complete
Location
GSK Investigational Site
Caulfield, Victoria, Australia, 3162
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78237
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Regina, Saskatchewan, Canada, S4P 3X1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Chester, Pennsylvania, United States, 19382
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63376
Status
Study Complete
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70461
Status
Study Complete
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Study Complete
Location
GSK Investigational Site
Los Banos, California, United States, 93635
Status
Study Complete
Location
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 0M5
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3V9
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Georgia, United States, 30189
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Kingston, New York, United States, 12401
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99207
Status
Study Complete
Location
GSK Investigational Site
St. Cloud, Florida, United States, 34769
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78221
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76017
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
Perth, Western Australia, Australia, 6000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
Fremantle, Western Australia, Australia, 6959
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9H 5G1
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fayetteville, Georgia, United States, 30214
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60607
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Warminster, Pennsylvania, United States, 18974
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint Marc Des Carrieres, Québec, Canada, G0A 4B0
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98108
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9J 7B3
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newburgh, Indiana, United States, 47630
Status
Study Complete
Location
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32204
Status
Study Complete
Location
GSK Investigational Site
Calgary, Alberta, Canada, T3E 0C5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78411
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sainte Jerome, Québec, Canada, J7Z 5T3
Status
Study Complete
Location
GSK Investigational Site
Courtice, Ontario, Canada, L1E 3C3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-30-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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