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Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 30, 2005
First Posted Date  ICMJE October 4, 2005
Results First Submitted Date  ICMJE October 15, 2013
Results First Posted Date  ICMJE May 28, 2015
Last Update Posted Date December 14, 2017
Study Start Date  ICMJE November 2003
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
Beta-cell Function
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • 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.
  • 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
  • Weight [ Time Frame: 72 months ]
    Body Weight
  • Inflammatory Markers - hsCRP [ Time Frame: 72 months ]
    Inflammatory markers - hsCRP (C reactive protein)
  • Inflammatory Markers -Fibrinogen [ Time Frame: 72 months ]
    Inflammatory markers - Fibrinogen
  • Inflammatory Markers - PAI-1 [ Time Frame: 72 months ]
    Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
  • Insulin Resistance (HOMA)
  • Glycemic Control
  • Weight Change
  • Inflammatory Markers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Metformin
    Metformin 1000mg/BID
  • Drug: Insulin
    Insulin Novolg 70/30 per protocol titration
  • Drug: Metfomin
    Metformin 1000mg/BID
  • Drug: Pioglitazone
    Pioglitazone 45mg
  • Drug: glyburide
    Glyburide per protocol titration
Study Arms  ICMJE
  • Active Comparator: Metfomin and Insulin
    Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration
    Interventions:
    • Drug: Metformin
    • Drug: Insulin
  • Active Comparator: Metformin, Pioglitazone and Glyburide
    Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
    Interventions:
    • Drug: Metfomin
    • Drug: Pioglitazone
    • Drug: glyburide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2007)
58
Original Enrollment  ICMJE
 (submitted: September 30, 2005)
60
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00232583
Other Study ID Numbers  ICMJE 1003-623
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ildiko Lingvay, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Raskin, MD University of Texas
Principal Investigator: Ildiko Lingvay, MD University of Texas
PRS Account University of Texas Southwestern Medical Center
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP