Adults 21 to 50, any sex, with Diabetes Mellitus or Endocrine System Diseases. 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.
Insulin SensitivityPrimary· Day 7
Insulin sensitivity determined by Hyperinsulinemic-Euglycemic Clamp as the glucose infusion rate (GIR) per fat-free-mass (FFM) during high dose insulin infusion
Group
Value
95% CI
Placebo
12.0
± 4.3
GSK2256294
11.6
± 3.7
Forearm Blood Flow (FBF)Secondary· Day 7
Insulin stimulated forearm blood flow determined by strain-gauge plethysmography
Group
Value
95% CI
Placebo
3.5
± 1.9
GSK2256294
3.1
± 1.2
Insulin Signaling in TissueSecondary· Day 7
Insulin stimulated phosphorylated AKT to total AKT ratio (pAKT/AKT) in adipose and muscle tissue sample. AKT is an insulin sensitive serine/threonine kinase also known as protein kinase B.
Soluble Epoxide Hydrolase ActivitySecondary· Day 7
soluble epoxide hydrolase (sEH) activity measured by 14,15-DHET conversion rate in plasma
Group
Value
95% CI
Placebo
4.1
± 4.5
GSK2256294
1.9
± 2.6
Renal Plasma Flow (RPF)Secondary· Day 7
Renal plasma flow determined by PAH infusion, ml/min/per 1.73 m\^2 body surface area
Group
Value
95% CI
Placebo
648
± 138
GSK2256294
614
± 103
Plasma Total Epoxyeicosatrienoic Acids (EETs)Secondary· Day 7
total Epoxyeicosatrienoic acids in plasma
Group
Value
95% CI
Placebo
21.4
± 8.4
GSK2256294
22.4
± 9.3
Plasma IL-6Secondary· Day 7
Plasma cytokine interleukin-6 (IL-6)
Group
Value
95% CI
Placebo
1.48
± 0.61
GSK2256294
1.48
± 0.69
Plasma VEGFSecondary· Day 7
Plasma vascular endothelial growth factor (VEGF)
Group
Value
95% CI
Placebo
31.9
± 18.6
GSK2256294
29.0
± 24.4
Adipose Tissue Total Epoxyeicosatrienoic Acids (EETs)Secondary· Day 7
total Epoxyeicosatrienoic acids in adipose tissue (pmol per mg tissue)
Group
Value
95% CI
Placebo
176
± 291
GSK2256294
66
± 44
Soluble Epoxide Hydrolase Activity in TissueSecondary· Day 7
soluble epoxide hydrolase (sEH) activity measured by 14,15-DHET conversion rate in adipose and muscle, per mg tissue
Adipose
Group
Value
95% CI
Placebo
2176
± 965
GSK2256294
1280
± 675
Muscle
Group
Value
95% CI
Placebo
3.5
± 1.6
GSK2256294
1.9
± 1.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline to one month post-intervention (approximately 3 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to test how soluble epoxide hydrolase (sEH) inhibition with GSK2256294 affects tissue sEH activity and insulin sensitivity.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02262689 — To Evaluate Effects of GSK2256294 on Pulmonary Artery Pressure in Healthy Volunteers Under Normoxic and Hypoxic Conditio
· Phase 1
· completed
NCT02006537 — A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly
· Phase 1
· completed
NCT01762774 — A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healt
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 23 March 2023
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/NCT03486223.