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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

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

U.S. FDA Resources

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

Primary Outcome Measures:

Beta-cell function [ Time Frame: 72 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin resistance (HOMA) [ Time Frame: 72 mo ] [ Designated as safety issue: No ]
Glycemic control [ Time Frame: 72 mo ] [ Designated as safety issue: No ]
Weight change [ Time Frame: 72 mo ] [ Designated as safety issue: No ]
Inflammatory markers [ Time Frame: 72 mo ] [ Designated as safety issue: No ]
quality of life, treatment satisfaction, and treatment compliance [ Time Frame: 72mo ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	November 2003
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Insulin per protocol titration, Metformin 1000 mg BID, Pioglitazone 45 mg daily, Glyburide per protocol tiration

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:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lingvay I, Legendre JL, Kaloyanova PF, Zhang S, Adams-Huet B, Raskin P. Insulin-based versus triple oral therapy for newly diagnosed type 2 diabetes: which is better? Diabetes Care. 2009 Oct;32(10):1789-95. Epub 2009 Jul 10.

Responsible Party:	UT Southwestern Medical Center ( Philip Raskin, MD )
Study ID Numbers:	1003-623
Study First Received:	September 30, 2005
Last Updated:	July 19, 2009
ClinicalTrials.gov Identifier:	NCT00232583 History of Changes
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

Additional relevant MeSH terms:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Physiological Effects of Drugs
Metformin

Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010