Trial Outcomes & Findings for Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome (NCT NCT00775671)

Results Overview

Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

After 12 weeks of study drug

Results posted on

2012-10-23

Participant Flow

Participants answered recruitment advertisments. All qualifying participants had Metabolic Syndrome.

Participants that met inclusion criteria stopped their antihypertensive medications for 3 weeks before study start. All participants took a placebo pill daily for 21 days and had baseline measurements done.

Participant milestones

Participant milestones
Measure	Nebivolol Nebivolol 5mg by mouth daily for 12 weeks.	Metoprolol Metoprolol ER 100mg by motuh daily for 12 weeks.
Overall Study STARTED	23	23
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nebivolol n=23 Participants Nebivolol 5mg by mouth daily for 12 weeks.	Metoprolol n=23 Participants Metoprolol ER 100mg by motuh daily for 12 weeks.	Total n=46 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	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	41.3 years STANDARD_DEVIATION 11.5 • n=5 Participants	47.4 years STANDARD_DEVIATION 8.5 • n=7 Participants	44.4 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: After 12 weeks of study drug

Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.

Outcome measures

Outcome measures
Measure	Nebivolol n=23 Participants Nebivolol 5mg by mouth daily for 12 weeks.	Metoprolol n=23 Participants Metoprolol ER 100mg by motuh daily for 12 weeks.
Marker of Fibrinolysis	10.5 ng/mL Standard Deviation 6.2	12.3 ng/mL Standard Deviation 7.8

SECONDARY outcome

Timeframe: 3 hours

The change in insulin sensitivity index, from baseline to after 12 weeks of treatment. Calculated from the intravenous glucose tolerance test at baseline and at 12 weeks.

Outcome measures

Outcome measures
Measure	Nebivolol n=23 Participants Nebivolol 5mg by mouth daily for 12 weeks.	Metoprolol n=23 Participants Metoprolol ER 100mg by motuh daily for 12 weeks.
Measurement of Insulin Sensitivity	0.04 10-4xmin-1 per mU/L Standard Deviation 2.19	-1.5 10-4xmin-1 per mU/L Standard Deviation 2.5

Adverse Events

Nebivolol

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Metoprolol

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nebivolol n=23 participants at risk Nebivolol 5mg by mouth daily for 12 weeks.	Metoprolol n=23 participants at risk Metoprolol ER 100mg by motuh daily for 12 weeks.
Respiratory, thoracic and mediastinal disorders congestion	39.1% 9/23 • Number of events 9 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.	8.7% 2/23 • Number of events 2 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.
General disorders Headache	13.0% 3/23 • Number of events 3 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.	4.3% 1/23 • Number of events 1 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.
General disorders Sore Throat	8.7% 2/23 • Number of events 2 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.	0.00% 0/23 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.
Renal and urinary disorders urinary tract infection	0.00% 0/23 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.	8.7% 2/23 • Number of events 2 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.
General disorders palpitations	0.00% 0/23 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.	8.7% 2/23 • Number of events 2 • 18 weeks Time from washing off antihypertensive medication, taking placebo for 21 days, and taking study drug for 12 weeks.

Additional Information

Nancy J Brown

Vanderbilt University

Phone: 615-343-8701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place