Status:
TERMINATED
Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone
Lead Sponsor:
Pfizer
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
45-70 years
Phase:
NA
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 w...
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.
Eligibility Criteria
Inclusion
- 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
- Evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00282945
Start Date
January 1 2006
End Date
October 1 2007
Last Update
October 13 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Holon, Israel, 58100
2
Pfizer Investigational Site
Jerusalem, Israel, 91120