Status:
COMPLETED
Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitaz...
Detailed Description
This is a 72 months long randomized clinical trial longitudinally evaluating beta-cell function, as well as glycemic control and inflammatory markers in newly diagnosed type 2 diabetic patients on two...
Eligibility Criteria
Inclusion
- type 2 diabetes mellitus diagnosed within the prior 2 months
- HbA1c \> 7% at the time of inclusion
- willing to perform intensive diabetes management
- able to comply with treatment and follow-up regimen
Exclusion
- HbA1c \> 8% at time of randomization
- creatinine \> 1.5 mg/dl
- liver function tests \> 3 times the upper limit of normal
- severe anemia
- severe proliferative retinopathy
- NYHA class III or IV heart failure
- active CAD or recent (within 6 months) MI
- pregnant, willing to get pregnant, or not willing to practice any contraceptive method
- non-english speaking
- active heavy alcohol or illicit drug users (within past 6 months)
- history of lactic acidosis
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00232583
Start Date
November 1 2003
End Date
December 1 2011
Last Update
December 14 2017
Active Locations (1)
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1
University of Texas Southwestern
Dallas, Texas, United States, 75390