Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 pioglitazone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Glyburide; Insulin; Insulin, Globin Zinc; Metformin; Pioglitazone

Criteria

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