Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

Completed · Not applicable

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00232583

Run by

University of Texas Southwestern Medical Center

People needed

58

Starts

2003-11-01

Expected to finish

2011-12-01

Last updated by the study team

2017-12-14

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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