Official Title: “Preservation of Beta-Cell Function in Type 2 Diabetes Mellitus”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: insulin & metformin vs. glyburide, metformin & pioglitazone

Primary Measures

• Beta-cell function
  • Time Frame: 72 mo
    

Secondary Measures

• Insulin resistance (HOMA)
  • Time Frame: 72 mo
    
• Glycemic control
  • Time Frame: 72 mo
    
• Weight change
  • Time Frame: 72 mo
    
• Inflammatory markers
  • Time Frame: 72 mo
    
• quality of life, treatment satisfaction, and treatment compliance
  • Time Frame: 72mo
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Texas Southwestern Medical Center

Overall Clinical Trial Officials and Contacts

Philip Raskin, MD Principal Investigator University of Texas Southwestern  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00232583

Study ID Number: 1003-623

ClinicalTrials.gov Identifier: NCT00232583

Health Authority: United States: Institutional Review Board