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: May 26, 2015
Last verified: October 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: Metformin
Drug: Insulin
Drug: Metfomin
Drug: Pioglitazone
Drug: 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: Change from 0 to 72 months ] [ Designated as safety issue: No ]
    C-peptide AUC during a 3-HR MMCT


Secondary Outcome Measures:
  • Insulin Resistance (HOMA) [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Glycemic Control [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Weight Change [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Inflammatory Markers [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Quality of Life, Treatment Satisfaction, and Treatment Compliance [ Time Frame: 72months ] [ 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 and Insulin
Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration
Drug: Metformin
Metformin 1000mg/BID
Drug: Insulin
Insulin Novolg 70/30 per protocol titration
Active Comparator: Metformin, Pioglitazone and Glyburide
Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
Drug: Metfomin
Metformin 1000mg/BID
Drug: Pioglitazone
Pioglitazone 45mg
Drug: glyburide
Glyburide per protocol titration

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: October 15, 2013
Last Updated: May 26, 2015
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glyburide
Insulin
Metformin
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 01, 2015