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Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT00123643
Recruitment Status : Completed
First Posted : July 25, 2005
Results First Posted : August 9, 2012
Last Update Posted : July 15, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Aaron S. Kelly, Ph.D., University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Type 2 Diabetes Mellitus
Interventions Drug: rosiglitazone
Drug: glyburide
Enrollment 36
Recruitment Details recruitment was performed at medical clinics
Pre-assignment Details patients taking thiazolidinediones or sulfonylureas were allowed to washout of these medications 30 days prior to randomization
Arm/Group Title Rosiglitazone Glyburide
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 20 16
Completed 20 16
Not Completed 0 0
Arm/Group Title Rosiglitazone Glyburide Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 20 16 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 16 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  80.0%
8
  50.0%
24
  66.7%
>=65 years
4
  20.0%
8
  50.0%
12
  33.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 16 participants 36 participants
57.9  (8.2) 63.1  (7.8) 60.2  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 16 participants 36 participants
Female
11
  55.0%
6
  37.5%
17
  47.2%
Male
9
  45.0%
10
  62.5%
19
  52.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 16 participants 36 participants
20 16 36
1.Primary Outcome
Title Flow Mediated Dilation
Hide Description Measure of endothelial function
Time Frame change from baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All completers were analyzed
Arm/Group Title Rosiglitazone Glyburide
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 16
Mean (Standard Deviation)
Unit of Measure: percent change
6.8  (3.7) 5.5  (3.1)
Time Frame 6-months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rosiglitazone Glyburide
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Rosiglitazone Glyburide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rosiglitazone Glyburide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rosiglitazone Glyburide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/16 (0.00%) 
Small sample size; unbalanced sex distribution between groups
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
Name/Title: Aaron S. Kelly, Ph.D.
Organization: University of Minnesota
Phone: 612-626-3492
Responsible Party: Aaron S. Kelly, Ph.D., University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00123643     History of Changes
Other Study ID Numbers: GSK2002-2
First Submitted: July 21, 2005
First Posted: July 25, 2005
Results First Submitted: July 2, 2012
Results First Posted: August 9, 2012
Last Update Posted: July 15, 2013