Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone
Not Applicable
Terminated
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00282945
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine whether markers of b-cell function can predict changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM) randomized to treatment with metformin or rosiglitazone.
- Detailed Description
The study terminated on 17-Jul-07 due to concerns about long-term cardiovascular safety of Avandia and slow patient enrollment. There were no specific safety issues raised within the trial.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
- Male or female with type diabetes mellitus (diagnosed via ADA criteria), newly diagnosed or treatment-naive (other than diet and exercise) and HbA1c range of 7 to 9%.
- 45-70 years of age.
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method This study will examine whether biomarkers of B-cell function measured early in the study (1, 3, and/or 6 months) will predict long-term changes in B-cell function (as represented by HOMA-B).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇮🇱Jerusalem, Israel