Last updated: 11/04/2018 02:59:06
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients with Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Trial description: The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Rosiglitazone
Drug: glyburide
Drug: metformin
Enrollment:
4426
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care, Vol 25, No. 10, October, 2002.
A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of Type 2 diabetic patients in North America and Europe. Diabetic Medicine, November, 2006.
Glycemic Durability of Rosiglitazone, Metformin, or Glyburide Monotherapy. N Eng J Med: 355:2427-43, December, 2006.
Obesity is a Major Determinant of the Association of C-Reactive Protein Levels and the Metabolic Syndrome in Type 2 Diabetes. Diabetes, August, 2006
Phenotypic Characteristics of Glutamic Acid Decarboxylase Antibody Positive, Recently Diagnosed Subjects with Type 2 Diabetes in North America and Europe. Diabetes, December, 2004.
Kahn S, Lachin J, Zinman B, Haffner S, Aftring R, Paul G, Kravitz B, Herman W, Viberti G, Holman R. Effects of rosiglitazone, glyburide and metformin on ß-cell function and insulin sensitivity in ADOPT. Diabetes. 2011;.(Mar 17)
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
January 2000 to June 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30 - 75 years
Accepts healthy volunteers
No
- Newly diagnosed patients (< 3years) with type 2 diabetes.
- Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
- History of lactic acidosis.
- Anemia (<11g for males, <10 g for females).
Inclusion and exclusion criteria
Inclusion criteria:
- Newly diagnosed patients (< 3years) with type 2 diabetes.
- Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
- No previous treatment with oral or parenteral glucose-lowering therapy.
Exclusion criteria:
- History of lactic acidosis.
- Anemia (<11g for males, <10 g for females).
- Unstable or severe NY Heart Association-class 3 or 4.
- Any NY Heart Association congestive heart failure.
- Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
Trial location(s)
Location
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom
0.6 miles (1.0 km) away from your location
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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-19-06
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
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