Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 25 - 65 |
| Updated: | 12/16/2017 |
| Start Date: | November 2003 |
| End Date: | December 2011 |
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 pioglitazone.
patients on two different treatment regimens: insulin and metformin versus glyburide,
metformin and pioglitazone.
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 different treatment regimens: insulin and metformin versus
glyburide, metformin and pioglitazone.
function, as well as glycemic control and inflammatory markers in newly diagnosed type 2
diabetic patients on two different treatment regimens: insulin and metformin versus
glyburide, metformin and pioglitazone.
Inclusion Criteria:
- 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 Criteria:
- 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
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