Preservation of Beta-cell Function in Type 2 Diabetes Mellitus | RxWiki

Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

Overview[ - collapse ][ - ]

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	Type 2 Diabetes Mellitus
Intervention	Drug: Metfomin & Insulin Drug: Metformin, pioglitazone, glyburide
Phase	N/A
Sponsor	University of Texas Southwestern Medical Center
Responsible Party	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier	NCT00232583
First Received	September 30, 2005
Last Updated	January 22, 2013
Last verified	January 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 30, 2005
Last Updated Date	January 22, 2013
Start Date	November 2003
Estimated Primary Completion Date	December 2011
Current Primary Outcome Measures	Beta-cell function [Time Frame: 72 mo] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Official Title	Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Brief 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.
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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Metfomin & Insulin Metfomin 1000mg/BID Insulin Novolg 70/30 per protocol titration Drug: Metformin, pioglitazone, glyburide Metformin 1000mg/bid Glyburide per protocol titration Pioglitazone 45mg
Study Arm (s)	Active Comparator: Metfomin, Insulin & Metfomin, pioglitazone, glyburide

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	58
Estimated Completion Date	December 2011
Estimated Primary Completion Date	December 2011
Eligibility 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
Gender	Both
Ages	25 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00232583
Other Study ID Numbers	1003-623
Has Data Monitoring Committee	No
Information Provided By	University of Texas Southwestern Medical Center
Study Sponsor	University of Texas Southwestern Medical Center
Collaborators	Not Provided
Investigators	Principal Investigator: Philip Raskin, MD University of TexasPrincipal Investigator: Ildiko Lingvay, MD University of Texas
Verification Date	January 2013

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