Portal Insulin U-500 intraperitoneal euglycemic clamp
What this study tests
Recruiting US Phase 1 single-bolus 12-hour euglycemic clamp of Portal Diabetes’ investigational intraperitoneal U-500 insulin (PI-U500) in adults with Type 1 diabetes, compared with intraperitoneal Humulin R U-500 and subcutaneous Lyumjev U-100 per the registry. Safety, pharmacokinetics and glucodynamics are the listed focus. No results posted.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-04-28.
Most recent recorded citation date: 2026-04-28. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults 18–60 with T1D for at least 12 months on a pump or basal-bolus regimen with stable use for 3 months, fasting C-peptide at most 0.3 nmol/L (0.9061 ng/mL per the registry) assessed when plasma glucose is above 90 mg/dL (carbohydrates may be given to raise glucose above that threshold before the draw, per the registry). Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. Per the registry: recruiting; enrollment 25 (estimated); actual start 10 February 2026; primary completion September 2026 (estimated). Last registry update posted 28 April 2026. A single-bolus clamp is not a closed-loop intraperitoneal pump result.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Safety: incidence of adverse events, from enrollment until the follow-up visit (an average of 2 months), per the registry
- Safety: change from baseline in systolic and diastolic blood pressure, and change from baseline in temperature — each measured within 4 hours before drug administration and after 12 hours of drug administration, per the registry
The full picture
Intraperitoneal delivery places insulin near the portal circulation; the registry describes this study as testing how rapidly the investigational PI-U500 is absorbed and how long it takes to act when given intraperitoneally. It is a single-bolus study under clamp conditions, not a test of a wearable pump in daily life.
The registry describes a 12-hour clamp in which blood glucose is held stable with glucose infusion at variable rates after a single intraperitoneal injection, with safety, pharmacokinetics and glucodynamics as the listed focus. That does not test whether an intraperitoneal pump would improve time in 70–180 mg/dL (3.9–10.0 mmol/L) at home. Estimated enrollment is 25.
Sources
- [1]