Trial Outcomes & Findings for Fenofibrate in Type 2 Diabetes (NCT NCT03829514)

Last Updated: 2023-10-24

Results Overview

Protein exclusive intensity values (counts/second) were normalized using cyclic loess normalization. Mean protein abundance as determined by the intensity for each protein was determined. 95% confidence intervals were calculated as a measure of dispersion. Paired means were compared using a Limma T-test and the p-value was adjusted for multiple comparisons using the Benjamini-Hochberg method. Mean Log2 Fold Change was calculated for each protein compared between 6 weeks and baseline. The number of proteins that changed between 6 weeks and baseline was zero.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Six weeks, from baseline visit to study completion visit

Results posted on

2023-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Fenofibrate Single arm. Participants will take study medication Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides \>150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fenofibrate in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fenofibrate n=10 Participants Single arm. Participants will take study medication Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides \>150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Number of proteins and their relative abundance	667 proteins n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Six weeks, from baseline visit to study completion visit

Population: One participant sample lacked quantity to test.

Outcome measures

Outcome measures
Measure	Fenofibrate n=667 proteins Single arm. Participants will take study medication Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides \>150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
Number of Individual Plasma Proteins That Changed From Baseline to End-point Based on Limma T-Test of Protein Abundance as Determined by Proteomic Analysis Via Liquid Chromatography-mass Spectrometry	0 Proteins Interval -2.0 to 2.0

Adverse Events

Fenofibrate

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

Misti Leyva

Medical University of South Carolina

Phone: endo office

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place