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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

Page last updated: August 23, 2015

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