Trial Outcomes & Findings for Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients (NCT NCT00123643)

NCT ID: NCT00123643

Last Updated: 2013-07-15

Results Overview

Measure of endothelial function

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: change from baseline to 6 months
• Results posted on: 2013-07-15

Participant Flow

recruitment was performed at medical clinics

patients taking thiazolidinediones or sulfonylureas were allowed to washout of these medications 30 days prior to randomization

Participant milestones

Measure	Rosiglitazone	Glyburide
Overall Study STARTED	20	16
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

Baseline characteristics by cohort

Measure	Rosiglitazone n=20 Participants	Glyburide n=16 Participants	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Age Continuous	57.9 years STANDARD_DEVIATION 8.2 • n=5 Participants	63.1 years STANDARD_DEVIATION 7.8 • n=7 Participants	60.2 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	16 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: change from baseline to 6 months

Population: All completers were analyzed

Measure of endothelial function

Outcome measures

Measure	Rosiglitazone n=20 Participants	Glyburide n=16 Participants
Flow Mediated Dilation	6.8 percent change Standard Deviation 3.7	5.5 percent change Standard Deviation 3.1

Adverse Events

Rosiglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glyburide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron S. Kelly, Ph.D.

University of Minnesota

Phone: 612-626-3492

Email: kelly105@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place