Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

• 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: St. Paul Heart Clinic
• 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

Participant Flow

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
Arm/Group Description	[Not Specified]	[Not Specified]
Period Title: Overall Study
Started	20	16
Completed	20	16
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Rosiglitazone	Glyburide	Total
Arm/Group Description		[Not Specified]	[Not Specified]	Total of all reporting groups
Overall Number of Baseline Participants		20	16	36
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

Outcome Measures

1. Primary Outcome

Title	Flow Mediated Dilation
Description	Measure of endothelial function
Time Frame	change from baseline to 6 months

Outcome Measure Data

Analysis Population Description

All completers were analyzed

Arm/Group Title	Rosiglitazone	Glyburide
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)

Adverse Events

Time Frame	6-months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Rosiglitazone	Glyburide
Arm/Group Description	[Not Specified]	[Not Specified]
All-Cause Mortality
	Rosiglitazone	Glyburide
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Rosiglitazone	Glyburide
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/16 (0.00%)
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%)

Limitations and Caveats

Small sample size; unbalanced sex distribution between groups

More Information

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
• EMail: kelly105@umn.edu

• 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