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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Metformin
Drug: Insulin
Drug: Metfomin
Drug: Pioglitazone
Drug: glyburide
Enrollment 58
Recruitment Details Patients recruited at UT Southwestern Clinical Diabetes Research Office
Pre-assignment Details A 3-months run-in period preceeded randomization. During this period all patients were treated with insulin and metformin.
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose). Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Period Title: Overall Study
Started 29 29
Completed 19 16
Not Completed 10 13
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide Total
Hide Arm/Group Description Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose). Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily). Total of all reporting groups
Overall Number of Baseline Participants 29 29 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
29
 100.0%
58
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 29 participants 58 participants
44.8  (9.7) 45.0  (10.7) 44.9  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
Female
9
  31.0%
12
  41.4%
21
  36.2%
Male
20
  69.0%
17
  58.6%
37
  63.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 29 participants 58 participants
29 29 58
1.Primary Outcome
Title Beta-cell Function - C-peptide AUC (Area Under the Curve)
Hide Description C-peptide AUC during a 3-hours mixed meal challenge testing
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin & Insulin Metformin, GLyburide & Pioglitazone
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: ng*min/mL
2096  (795) 1725  (618)
2.Secondary Outcome
Title Insulin Sensitivity as Measure be Matsuda Index
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: index
3.12  (2.62) 2.45  (1.09)
3.Secondary Outcome
Title Bet-cell Function Measured by Disposition Index
Hide Description 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
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: index
0.12  (0.07) 0.16  (0.09)
4.Secondary Outcome
Title Weight
Hide Description Body Weight
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin and Insulin Metformin, Pioglitazone and Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: kg
107.7  (31.1) 107.9  (31.4)
5.Secondary Outcome
Title Inflammatory Markers - hsCRP
Hide Description Inflammatory markers - hsCRP (C reactive protein)
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: mg/L
6.9  (7.7) 6.1  (8.9)
6.Secondary Outcome
Title Inflammatory Markers -Fibrinogen
Hide Description Inflammatory markers - Fibrinogen
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: mg/dL
399.0  (82.6) 395.4  (98.5)
7.Secondary Outcome
Title Inflammatory Markers - PAI-1
Hide Description Inflammatory markers - PAI-1 (Plasminogen activator inhibitor type 1)
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: IU/L
13.9  (11.7) 16.7  (18.0)
8.Secondary Outcome
Title Quality of Life Survey (QoL) - Current Health Perception
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.7  (0.9) 2.9  (0.9)
9.Secondary Outcome
Title Quality of Life Survey (QoL) - Treatment Satisfaction
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.7  (0.5) 2.1  (0.8)
10.Secondary Outcome
Title Quality of Life Survey (QoL) - Treatment Impact
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a sale
1.7  (0.2) 1.8  (0.3)
11.Secondary Outcome
Title Quality of Life Survey (QoL) - Social or Vocational Worry
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.8  (0.3) 1.7  (0.3)
12.Secondary Outcome
Title Quality of Life Survey (QoL) - Hypoglycemia Fear
Hide Description 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
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.8  (0.3) 1.8  (0.4)
13.Secondary Outcome
Title Quality of Life Survey (QoL) - Glycemia Control Perception
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.8  (2.8) 2.0  (2.0)
14.Secondary Outcome
Title Quality of Life Survey (QoL) - Lifestyle Flexibility
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.1  (0.6) 2.0  (0.6)
15.Secondary Outcome
Title Quality of Life Survey (QoL) - Social Stigma
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.2  (1.2) 2.2  (1.7)
16.Secondary Outcome
Title Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected from participants in the "Metfomin, Pioglitazone & Glyburide" Arm/Group since patients did not receive insulin.
Arm/Group Title Metfomin & Insulin
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.2  (0.9)
17.Secondary Outcome
Title Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment
Hide Description 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.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected from participants in the "Metfomin, Pioglitazone & Glyburide" Arm/Group since patients did not receive insulin.
Arm/Group Title Metfomin & Insulin
Hide Arm/Group Description:
Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.4  (0.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Hide Arm/Group Description Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose). Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
All-Cause Mortality
Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      1/29 (3.45%)    
Cardiac disorders     
Cardiac arrest  [1]  1/29 (3.45%)  1 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
[1]
Cardiac arrest leading to sudden death.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metfomin & Insulin Metfomin, Pioglitazone & Glyburide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/29 (17.24%)      6/29 (20.69%)    
Gastrointestinal disorders     
GI disturbance * [1]  5/29 (17.24%)  15 6/29 (20.69%)  18
*
Indicates events were collected by non-systematic assessment
[1]
Gastrointestinal adverse events included the following conditions: nausea, diarrhea, flatulence and or vomiting. These events were not reported separately.
Relatively small trial, but longest (6-year) follow-up.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ildiko Lingvay
Organization: UT Southwestern Medical Center
Phone: 214-648-2779
EMail: ildiko.lingvay@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00232583    
Other Study ID Numbers: 1003-623
First Submitted: September 30, 2005
First Posted: October 4, 2005
Results First Submitted: October 15, 2013
Results First Posted: May 28, 2015
Last Update Posted: December 14, 2017