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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age Continuous
|
57.9 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
63.1 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
60.2 years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
16 participants
n=107 Participants
|
36 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: change from baseline to 6 monthsPopulation: 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place