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NCT03829514

Fenofibrate in Type 2 Diabetes

Completed Phase 4 Results posted Last updated 24 October 2023
What this trial tests

Phase 4 trial testing Fenofibrate in Diabetes Mellitus, Type II in 10 participants. Completed in 4 March 2020.

Timeline
4 February 2019
Primary endpoint
4 March 2020
4 March 2020

Quick facts

Lead sponsorMedical University of South Carolina
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment10
Start date4 February 2019
Primary completion4 March 2020
Estimated completion4 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 70, any sex, with Diabetes Mellitus, Type II. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · Six weeks, from baseline visit to study completion visit

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.

GroupValue95% CI
Fenofibrate0-2 – 2

Sponsor's own description

Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in diabetic retinopathy offers an important translational research opportunity. The investigator's global proteomic study will provide new clues as to how fenofibrate protects vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Fenofibrate

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type II

Currently open trials in the same condition.

Other Medical University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03829514.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing