Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Metformin (Drug); Insulin (Drug); Metfomin (Drug); Pioglitazone (Drug); glyburide (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s): Philip Raskin, MD, Principal Investigator, Affiliation: University of Texas Ildiko Lingvay, MD, Principal Investigator, Affiliation: University of Texas
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.
Clinical Details
Official title: Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Beta-cell Function
Secondary outcome: Insulin Resistance (HOMA)Glycemic Control Weight Change Inflammatory Markers Quality of Life, Treatment Satisfaction, and Treatment Compliance
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 different treatment regimens: insulin and metformin versus
glyburide, metformin and pioglitazone.
Eligibility
Minimum age: 25 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
University of Texas Southwestern, Dallas, Texas 75390, United States
Additional Information
Starting date: November 2003
Last updated: May 26, 2015
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