NCT00044460CompletedPhase 4
A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 142
- Primary Endpoint
- Change in HbA1c from baseline to Week 24.
Study Overview
Brief Summary
The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes
- •Drug-naive.
- •Laboratory test result for HbA1c of greater than or equal to 10%.
- •Written informed consent.
Exclusion Criteria
- •Prior use of antidiabetic medications within 3 months of screening.
- •Fluid retention (edema).
- •Significant liver disease.
- •Low red blood cells (anemia).
- •Severe or unstable angina (chest pain).
- •Congestive heart failure.
- •Severe high blood pressure.
- •Alcohol or drug abuse.
- •Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
Outcomes
Primary Outcomes
Change in HbA1c from baseline to Week 24.
Secondary Outcomes
- Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.
Investigators
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