Status:
COMPLETED
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 3 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2006
Estimated Enrollment :
4426 Patients enrolled
Trial Details
Trial ID
NCT00279045
Start Date
January 3 2000
End Date
June 19 2006
Last Update
November 29 2017
Active Locations (490)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Birmingham, Alabama, United States, 35233
3
GSK Investigational Site
Mesa, Arizona, United States, 85206
4
GSK Investigational Site
Tucson, Arizona, United States, 85723