Last updated: 11/04/2018 04:07:26
Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in hemoglobin A1c (HbA1c) at week 32.
Timeframe: at 32 week
Secondary outcomes:
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
Interventions:
Enrollment:
453
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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.
Medical condition
Diabetes Mellitus, Type 2
Product
metformin, rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
October 2003 to December 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- 18 to 70 years of age
- Clinical diagnosis of type 2 diabetes
- Clinically significant renal or hepatic disease
- Presence of anemia
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32204
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
Status
Study Complete
Location
GSK Investigational Site
Regina, Saskatchewan, Canada, S4S 3R8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kingston, New York, United States, 12401
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
St. Cloud, Florida, United States, 34769
Status
Study Complete
Location
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78221
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3V9
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 0M5
Status
Study Complete
Location
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
Status
Study Complete
Location
GSK Investigational Site
Calgary, Alberta, Canada, T3E 0C5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Perth, Western Australia, Australia, 6000
Status
Study Complete
Location
GSK Investigational Site
Fremantle, Western Australia, Australia, 6959
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63376
Status
Study Complete
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Status
Study Complete
Location
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Status
Study Complete
Location
GSK Investigational Site
Saint Insidore de Dorchester, Québec, Canada, G0S 2S0
Status
Study Complete
Location
GSK Investigational Site
Encinitas, California, United States, 92024
Status
Study Complete
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60607
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9H 5G1
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tijuana, Baja California Norte, Mexico, 22320
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9J 7B3
Status
Study Complete
Location
GSK Investigational Site
Stoney Creek, Ontario, Canada, L8G 2V6
Status
Study Complete
Location
GSK Investigational Site
Los Banos, California, United States, 93635
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70461
Status
Study Complete
Location
GSK Investigational Site
Newburgh, Indiana, United States, 47630
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99207
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Georgia, United States, 30189
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76017
Status
Study Complete
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Warminster, Pennsylvania, United States, 18974
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Study Complete
Location
GSK Investigational Site
Sainte Jerome, Québec, Canada, J7Z 5T3
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04020-041
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98108
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Georgia, United States, 30214
Status
Study Complete
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
Saint Marc Des Carrieres, Québec, Canada, G0A 4B0
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
West Chester, Pennsylvania, United States, 19382
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78237
Status
Study Complete
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-16-12
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.
Additional information about the trial
Participate in clinical trial
Additional information
http://ctr.gsk.co.uk/Summary/Rosiglitazone/III_712753_007.pdf
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