Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232583
• Other study ID #: 1003-623
• Status: Completed
• Phase: N/A
• First received: September 30, 2005
• Last updated: November 17, 2017
• Start date: November 2003
• Est. completion date: December 2011

Study information

• Verified date: November 2017
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Metformin
Metformin 1000mg/BID
• Insulin
Insulin Novolg 70/30 per protocol titration
• Metfomin
Metformin 1000mg/BID
• Pioglitazone
Pioglitazone 45mg
• glyburide
Glyburide per protocol titration

Locations

Country	Name	City	State
United States	University of Texas Southwestern	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lingvay I, Kaloyanova PF, Adams-Huet B, Salinas K, Raskin P. Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted. J Investig Med. 2007 Mar;55(2):62-8. doi: 10.2310/6650.2007.06036. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta-cell Function - C-peptide AUC (Area Under the Curve)	C-peptide AUC during a 3-hours mixed meal challenge testing	72 months
Secondary	Insulin Sensitivity as Measure be Matsuda Index	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.	72 months
Secondary	Bet-cell Function Measured by Disposition Index	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	72 months
Secondary	Weight	Body Weight	72 months
Secondary	Inflammatory Markers - hsCRP	Inflammatory markers - hsCRP (C reactive protein)	72 months
Secondary	Inflammatory Markers -Fibrinogen	Inflammatory markers - Fibrinogen	72 months
Secondary	Inflammatory Markers - PAI-1	Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1)	72 months
Secondary	Quality of Life Survey (QoL) - Current Health Perception	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.	72 months
Secondary	Quality of Life Survey (QoL) - Treatment Satisfaction	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.	72 months
Secondary	Quality of Life Survey (QoL) - Treatment Impact	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.	72 months
Secondary	Quality of Life Survey (QoL) - Social or Vocational Worry	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.	72 months
Secondary	Quality of Life Survey (QoL) - Hypoglycemia Fear	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	72 months
Secondary	Quality of Life Survey (QoL) - Glycemia Control Perception	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.	72 months
Secondary	Quality of Life Survey (QoL) - Lifestyle Flexibility	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.	72 months
Secondary	Quality of Life Survey (QoL) - Social Stigma	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.	72 months
Secondary	Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment	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.	72 months
Secondary	Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment	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.	72 months