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Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00232583
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : May 28, 2015
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Metformin Drug: Insulin Drug: Metfomin Drug: Pioglitazone Drug: glyburide Not Applicable

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  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Study Start Date : November 2003
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Beta-cell Function - C-peptide AUC (Area Under the Curve) [ Time Frame: 72 months ]
    C-peptide AUC during a 3-hours mixed meal challenge testing


Secondary Outcome Measures :
  1. Insulin Sensitivity as Measure be Matsuda Index [ Time Frame: 72 months ]
    C-peptide-based Matsuda index using following formula: Matsuda index = 500,00 / root square [(fasting c-peptide x fasting glucose x 333) x (average c-peptide 0-120 mins x average glucose 0-120 mins x 333). Higher the Matsuda index, better the insulin sensitivity.

  2. Bet-cell Function Measured by Disposition Index [ Time Frame: 72 months ]
    Disposition index was measured by multiplying the insulin secretion (C-peptide AUC/C-peptide AUC glucose) by the Matsuda index. Disposition index reflects the beta-cell function adjusted for total body insulin sensitivity

  3. Weight [ Time Frame: 72 months ]
    Body Weight

  4. Inflammatory Markers - hsCRP [ Time Frame: 72 months ]
    Inflammatory markers - hsCRP (C reactive protein)

  5. Inflammatory Markers -Fibrinogen [ Time Frame: 72 months ]
    Inflammatory markers - Fibrinogen

  6. Inflammatory Markers - PAI-1 [ Time Frame: 72 months ]
    Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1)

  7. Quality of Life Survey (QoL) - Current Health Perception [ Time Frame: 72 months ]
    Current health perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.

  8. Quality of Life Survey (QoL) - Treatment Satisfaction [ Time Frame: 72 months ]
    Treatment satisfaction was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.

  9. Quality of Life Survey (QoL) - Treatment Impact [ Time Frame: 72 months ]
    Treatment impact was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.

  10. Quality of Life Survey (QoL) - Social or Vocational Worry [ Time Frame: 72 months ]
    Social or vocational worry was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.

  11. Quality of Life Survey (QoL) - Hypoglycemia Fear [ Time Frame: 72 months ]
    Hypoglycemia fear was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry

  12. Quality of Life Survey (QoL) - Glycemia Control Perception [ Time Frame: 72 months ]
    Glycemia control perception was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled.

  13. Quality of Life Survey (QoL) - Lifestyle Flexibility [ Time Frame: 72 months ]
    Lifestyle flexibility was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.

  14. Quality of Life Survey (QoL) - Social Stigma [ Time Frame: 72 months ]
    Social stigma was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1- strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.

  15. Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment [ Time Frame: 72 months ]
    Satisfaction with insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.

  16. Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment [ Time Frame: 72 months ]
    Willingness to continue insulin treatment was measured at randomization and 72 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: October 4, 2005    Key Record Dates
Results First Posted: May 28, 2015
Last Update Posted: December 14, 2017
Last Verified: November 2017

Keywords provided by Ildiko Lingvay, 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
Insulin, Globin Zinc
Pioglitazone
Insulin
Metformin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs