Trial Outcomes & Findings for Niacin, N-3 Fatty Acids and Insulin Resistance (NCT NCT00286234)

Results Overview

Change From Baseline to 4 Months in Serum Triglycerides

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

68 participants

Primary outcome timeframe

4 months

Results posted on

2021-10-26

Participant Flow

Subjects were recruited from throughout the Sanford Clinic - Clinical Research Services in Sioux Falls by posted advertisements in public places and at sponsored health fairs.

68 subjects willing to participate and qualified were subjected to a 6 week single blind run in period where they were given placebo omega-3 and placebo niacin. "Baseline" was defined as values and metrics after this run in period.

Participant milestones

Participant milestones
Measure	Dual Placebo Dual placebo placebo: omacor placebo plus niaspan placebo	Niaspan niaspan extended release niacin: 2 g qpm	Lovaza lovaza omega-3 acid ethyl esters: 4 q qd	Combined Therapy combined therapy combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm
Overall Study STARTED	17	17	17	17
Overall Study COMPLETED	15	15	17	13
Overall Study NOT COMPLETED	2	2	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Dual Placebo Dual placebo placebo: omacor placebo plus niaspan placebo	Niaspan niaspan extended release niacin: 2 g qpm	Combined Therapy combined therapy combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm
Overall Study Protocol Violation	1	2	1
Overall Study Physician Decision	1	0	1
Overall Study Adverse Event	0	0	1

Baseline Characteristics

Niacin, N-3 Fatty Acids and Insulin Resistance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dual Placebo n=17 Participants Dual placebo placebo: omacor placebo plus niaspan placebo	Niaspan n=17 Participants niaspan extended release niacin: 2 g qpm	Lovaza n=17 Participants lovaza omega-3 acid ethyl esters: 4 q qd omega-3 acid ethyl esters: 4 g qd	Combined Therapy n=17 Participants combined therapy combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm	Total n=68 Participants Total of all reporting groups
Age, Continuous	45 years n=5 Participants	49 years n=7 Participants	44 years n=5 Participants	48 years n=4 Participants	46 years n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	33 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	35 Participants n=21 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Those subjects with complete data baseline to end

Change From Baseline to 4 Months in Serum Triglycerides

Outcome measures

Outcome measures
Measure	Dual Placebo n=15 Participants Dual placebo placebo: omacor placebo plus niaspan placebo	Niaspan n=15 Participants niaspan extended release niacin: 2 g qpm	Lovaza n=17 Participants lovaza omega-3 acid ethyl esters: 4 q qd omega-3 acid ethyl esters: 4 g qd	Combined Therapy n=13 Participants combined therapy combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm
Serum TG	233 mg/dl Standard Deviation 162	157 mg/dl Standard Deviation 52	176 mg/dl Standard Deviation 63	156 mg/dl Standard Deviation 56

SECONDARY outcome

Timeframe: baseline and 4 months

Population: all subjects with pre and post treatment data

Change From Baseline to 4 Months in Serum Non-HDL cholesterol

Outcome measures

Outcome measures
Measure	Dual Placebo n=15 Participants Dual placebo placebo: omacor placebo plus niaspan placebo	Niaspan n=15 Participants niaspan extended release niacin: 2 g qpm	Lovaza n=17 Participants lovaza omega-3 acid ethyl esters: 4 q qd omega-3 acid ethyl esters: 4 g qd	Combined Therapy n=13 Participants combined therapy combined treatment: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm
Non-HDL-C	145 mg/dl Standard Deviation 23	155 mg/dl Standard Deviation 43	133 mg/dl Standard Deviation 34	170 mg/dl Standard Deviation 36

Adverse Events

Dual Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Niaspan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lovaza

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Therapy

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

Dr. William Harris

Sanford School of Medicine, University of South Dakota

Phone: 16052716917

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place