A Phase 2 interventional study of GSK2256294 and Placebo oral capsule in Diabetes Mellitus, Endocrine System Diseases and Glucose Metabolism Disorders, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Vanderbilt University Medical Center · Phase 2, Interventional, and Prevention
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Among 390 studies in Prediabetic State with a site in United States — 83 open to participants now, 107 under way, 2 of them phase 3. Prediabetic State · United States.
Among the 390 studies in Prediabetic State with a site in United States, this one is the 313th largest by enrollment of the 362 interventional ones that give a count, is one of 17 that started in 2018, is one of 20 in phase 2, and was the 147th registered.
918 studies on the registry are indexed under Prediabetic State; 231 are open to participants now.
Browse Prediabetic State studies →83 of the 390 studies in Prediabetic State with a site in United States are open now. Recruiting first, the newest first:
Rahul Sachdeva · Sites in United States
Ages 18+ · Healthy volunteers
University of South Florida · Sites in United States
Ages 18–70
St. Louis University · Sites in United States
Ages 18–69
Morehouse School of Medicine · Sites in United States
Ages 12+ · Healthy volunteers
Penn State University · Sites in United States
Ages 25–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 144 Prediabetic State studies recruiting now, 51 (35%) set no upper age limit and 83 (58%) stop at 75 or younger; 12 take children under 18; 54 take healthy volunteers.
This study: 21 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
390 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 25 · Phase 3 16 · Phase 4 16
First in 1996; this study’s year is marked. 17 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Median enrollment 54 across the 362 interventional studies, 188 across the 28 observational. Of the 258 that completed or were terminated, 89 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
35 of 390 have an industry lead sponsor. The 10 most frequent:
Vanderbilt University Medical Center is the lead sponsor of 835 studies on the registry; 155 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 92 (73%) have results posted.
Vanderbilt University Medical Center has 2 studies filed under Prediabetic State — fewer than ten, so there is no comparison to draw.
45 of the studies in Prediabetic State with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06995378University of California, Los AngelesStudy EHR Risk Stratification Tools | 2026-11 |
| NCT05165706Stanford UniversityLongitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance | 2026-11-30 |
| NCT07450118University of DelawareNested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans | 2026-12 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT07868432Tufts UniversityGlycemic Impact of NNS Via the Gut Microbiome | 2026-12 |
Add all 45 to your calendar (.ics) → With an account.
Among the 390 studies in Prediabetic State with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to test how soluble epoxide hydrolase (sEH) inhibition with GSK2256294 affects tissue sEH activity and insulin sensitivity.
We will test the hypothesis that soluble epoxide hydrolase (sEH) inhibition with GSK2256294 improves insulin sensitivity using the gold-standard, hyperinsulinemic-euglycemic clamps, with stable isotope dilution to assess hepatic gluconeogenesis. We will assess insulin-stimulated vasodilation in the forearm using plethysmography and in the renal vasculature using para-aminohippurate (PAH, IND#133828) clearance. We will obtain adipose and muscle tissue before and after clamp to assess insulin signaling in these tissues.
Subjects are randomized to treatment with the sEH inhibitor GSK2256294 (10mg/day) or matching placebo for one week. On the seventh day of drug treatment, subjects will report to the CRC in the morning after an overnight fast to undergo a hyperinsulinemic-euglycemic clamp with adipose tissue biopsies.
During the Hyperinsulinemic-euglycemic clamp, insulin will be infused for 2 hours at low dose (20 mU/m2/min) and 2 hours at high dose (80 mU/m2/min) to assess insulin sensitivity. The Glucose Infusion Rate (GIR) will be adjusted to maintain glucose near 95 mg/dL. The average GIR during the final 30 minutes of the high dose period will be used as the measure of insulin sensitivity.
After completion of the study day, subjects will undergo a seven-week washout from study drug and then receive the opposite drug for one week. On the seventh day of treatment they will report to the CRC after an overnight fast and repeat the study day protocol.
918 studies on the registry are indexed under Prediabetic State; 231 are open to participants now.
This study's enrollment of 16 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Vanderbilt University Medical Center is the lead sponsor of 835 studies on the registry; 155 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 92 (73%) have results posted.
Compared within Prediabetic State, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pre-diabetes as defined by
For female subjects, the following conditions must be met:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive placebo oral capsule daily by mouth for 7 days, then seven week washout and then GSK2256294 daily by mouth for 7 days.
Drug: GSK2256294 · Drug: Placebo oral capsule
Subjects will receive GSK2256294 daily by mouth for 7 days, then seven week washout and then placebo oral capsule daily by mouth for 7 days.
Drug: GSK2256294 · Drug: Placebo oral capsule
Drug will be taken daily by mouth for 7 days.
Also known as: GSK2256294 10mg oral capsule
Placebo will be taken daily by mouth for 7 days.
Also known as: Placebo
Insulin Sensitivity
Insulin sensitivity determined by Hyperinsulinemic-Euglycemic Clamp as the glucose infusion rate (GIR) per fat-free-mass (FFM) during high dose insulin infusion
Time frame: Day 7
Forearm Blood Flow (FBF)
Insulin stimulated forearm blood flow determined by strain-gauge plethysmography
Time frame: Day 7
Insulin Signaling in Tissue
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.
Time frame: Day 7
Blood Pressure
determined by non-invasive brachial blood pressure measurement (systolic blood pressure, SBP; diastolic blood pressure, DBP)
Time frame: Day 7
Renal Plasma Flow (RPF)
Renal plasma flow determined by PAH infusion, ml/min/per 1.73 m\^2 body surface area
Time frame: Day 7
Soluble Epoxide Hydrolase Activity
soluble epoxide hydrolase (sEH) activity measured by 14,15-DHET conversion rate in plasma
Time frame: Day 7
Plasma Total Epoxyeicosatrienoic Acids (EETs)
total Epoxyeicosatrienoic acids in plasma
Time frame: Day 7
Plasma IL-6
Plasma cytokine interleukin-6 (IL-6)
Time frame: Day 7
Plasma VEGF
Plasma vascular endothelial growth factor (VEGF)
Time frame: Day 7
Adipose Tissue Total Epoxyeicosatrienoic Acids (EETs)
total Epoxyeicosatrienoic acids in adipose tissue (pmol per mg tissue)
Time frame: Day 7
Soluble Epoxide Hydrolase Activity in Tissue
soluble epoxide hydrolase (sEH) activity measured by 14,15-DHET conversion rate in adipose and muscle, per mg tissue
Time frame: Day 7
35 volunteers were screened for inclusion
| Milestone | Placebo Then GSK2256294 | GSK2256294 Then Placebo |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 7 |
| Not completed | 0 | 1 |
| Withdrew: Received oral steroids for sinus infection; randomized but did not receive intervention | 0 | 1 |
| Milestone | Placebo Then GSK2256294 | GSK2256294 Then Placebo |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 7 |
| Not completed | 0 | 0 |
| Milestone | Placebo Then GSK2256294 | GSK2256294 Then Placebo |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 7 |
| Not completed | 0 | 0 |
Insulin sensitivity determined by Hyperinsulinemic-Euglycemic Clamp as the glucose infusion rate (GIR) per fat-free-mass (FFM) during high dose insulin infusion
| mg/kg/FFM/min | Placebo | GSK2256294 |
|---|---|---|
| Insulin Sensitivity | 12.0 ± 4.3 | 11.6 ± 3.7 |
Insulin stimulated forearm blood flow determined by strain-gauge plethysmography
| ml/min/100ml | Placebo | GSK2256294 |
|---|---|---|
| Forearm Blood Flow (FBF) | 3.5 ± 1.9 | 3.1 ± 1.2 |
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.
| pAKT/pAKT ratio | Placebo | GSK2256294 |
|---|---|---|
| Adipose Tissue | 0.21 ± 0.14 | 0.19 ± 0.18 |
| Muscle Tissue | 0.74 ± 0.55 | 0.73 ± 0.58 |
determined by non-invasive brachial blood pressure measurement (systolic blood pressure, SBP; diastolic blood pressure, DBP)
| mmHg | Placebo | GSK2256294 |
|---|---|---|
| SBP | 122.9 ± 11.0 | 124.3 ± 9.6 |
| DBP | 77.4 ± 6.8 | 78.9 ± 8.7 |
soluble epoxide hydrolase (sEH) activity measured by 14,15-DHET conversion rate in plasma
| pmol 14,15-DHET/ml/hr | Placebo | GSK2256294 |
|---|---|---|
| Soluble Epoxide Hydrolase Activity | 4.1 ± 4.5 | 1.9 ± 2.6 |
Renal plasma flow determined by PAH infusion, ml/min/per 1.73 m\^2 body surface area
| ml/min/per 1.73 m^2 | Placebo | GSK2256294 |
|---|---|---|
| Renal Plasma Flow (RPF) | 648 ± 138 | 614 ± 103 |
total Epoxyeicosatrienoic acids in plasma
| pmol/mL | Placebo | GSK2256294 |
|---|---|---|
| Plasma Total Epoxyeicosatrienoic Acids (EETs) | 21.4 ± 8.4 | 22.4 ± 9.3 |
Plasma cytokine interleukin-6 (IL-6)
| pmol/ml | Placebo | GSK2256294 |
|---|---|---|
| Plasma IL-6 | 1.48 ± 0.61 | 1.48 ± 0.69 |
Plasma vascular endothelial growth factor (VEGF)
| pg/ml | Placebo | GSK2256294 |
|---|---|---|
| Plasma VEGF | 31.9 ± 18.6 | 29.0 ± 24.4 |
total Epoxyeicosatrienoic acids in adipose tissue (pmol per mg tissue)
| pmol/mg | Placebo | GSK2256294 |
|---|---|---|
| Adipose Tissue Total Epoxyeicosatrienoic Acids (EETs) | 176 ± 291 | 66 ± 44 |
soluble epoxide hydrolase (sEH) activity measured by 14,15-DHET conversion rate in adipose and muscle, per mg tissue
| pmol 14,15-DHET/mg tissue/hr | Placebo | GSK2256294 |
|---|---|---|
| Adipose | 2176 ± 965 | 1280 ± 675 |
| Muscle | 3.5 ± 1.6 | 1.9 ± 1.1 |
Collected over Baseline to one month post-intervention (approximately 3 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| GSK2256294 | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Event | Placebo | GSK2256294 |
|---|---|---|
| Rash at biopsy dressing siteSkin and subcutaneous tissue disorders | 2/15 | 1/15 |
| FlushingGeneral disorders | 0/15 | 1/15 |
| HeadacheNervous system disorders | 1/15 | 1/15 |
| Increased frequency of bowel movementsGastrointestinal disorders | 1/15 | 1/15 |
| nauseaGastrointestinal disorders | 1/15 | 0/15 |
| Paresthesia of lipsNervous system disorders | 1/15 | 0/15 |
| PolyuriaRenal and urinary disorders | 1/15 | 0/15 |
| Increased thirstRenal and urinary disorders | 0/15 | 1/15 |
1 participant included here (in GSK-then-placebo arm) was randomized but did not receive intervention or complete a study day
| Age, Continuous(years) | Placebo Then GSK2256294 | GSK2256294 Then Placebo | Total |
|---|---|---|---|
| Mean | 45 ± 8 | 48 ± 10 | 47 ± 9 |
| Sex: Female, Male(Participants) | Placebo Then GSK2256294 | GSK2256294 Then Placebo | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 0 | 2 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Then GSK2256294 | GSK2256294 Then Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 8 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo Then GSK2256294 | GSK2256294 Then Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 5 | 6 | 11 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo Then GSK2256294 | GSK2256294 Then Placebo | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
| Glucose(mg/dl) | Placebo Then GSK2256294 | GSK2256294 Then Placebo | Total |
|---|---|---|---|
| Mean | 97 ± 8 | 96 ± 8 | 97 ± 8 |
| Body mass index(kg/m^2) | Placebo Then GSK2256294 | GSK2256294 Then Placebo | Total |
|---|---|---|---|
| Mean | 39 ± 7 | 43 ± 9 | 41 ± 8 |
| Waist circumference(cm) | Placebo Then GSK2256294 | GSK2256294 Then Placebo | Total |
|---|---|---|---|
| Mean | 112 ± 14 | 121 ± 24 | 116 ± 20 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Available upon request.
Ran from May 2018 to primary completion in Nov 2021, 42 months.
Results were first posted in Mar 2023, 1 year 4 months after primary completion.
Of 27 phase 2 interventional studies under Prediabetic State, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 69. This study's 42 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gsk-2256294
Vanderbilt University Medical Center →