Preservation of Beta-Cell Function in Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00232583

Purpose

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.

Condition	Intervention
Type 2 Diabetes Mellitus	Drug: insulin & metformin vs. glyburide, metformin & pioglitazone

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Pioglitazone Pioglitazone hydrochloride Glyburide Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Preservation of Beta-Cell Function in Type 2 Diabetes Mellitus

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

Beta-cell function [ Time Frame: 72 mo ]

Secondary Outcome 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 ]

Enrollment:	58
Study Start Date:	November 2003
Estimated Study Completion Date:	April 2011

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

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232583

Locations

United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:	Philip Raskin, MD	University of Texas Southwestern
Principal Investigator:	Ildiko Lingvay, MD	University of Texas Southwestern

More Information

Publications of Results:

Lingvay I, Kaloyanova PF, Adams-Huet B, Salinas K, Raskin P. Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted. J Investig Med. 2007 Mar;55(2):62-8.

Study ID Numbers:	1003-623
Study First Received:	September 30, 2005
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00232583
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

TYpe 2 diabetes mellitus
Newly diagnosed
Beta-cell function

Study placed in the following topic categories:

Glyburide
Metabolic Diseases
Pioglitazone
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009