Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00232583
First received: September 30, 2005
Last updated: January 22, 2013
Last verified: January 2013
  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: Metfomin & Insulin
Drug: Metformin, pioglitazone, glyburide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

Resource links provided by NLM:


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
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metfomin, Insulin & Metfomin, pioglitazone, glyburide 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

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
Principal Investigator: Ildiko Lingvay, MD University of Texas
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00232583     History of Changes
Other Study ID Numbers: 1003-623
Study First Received: September 30, 2005
Last Updated: January 22, 2013
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Glyburide
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014