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Phase 1RecruitingNCT07341373

Portal Insulin U-500 intraperitoneal euglycemic clamp

Recruiting US Phase 1 single-bolus 12-hour euglycemic clamp of Portal Diabetes’ intraperitoneal U-500 insulin in adults with Type 1 diabetes, compared with intraperitoneal Humulin R U-500 and subcutaneous Lyumjev U-100. Safety and how fast the dose acts are the questions. No results.

Primary endpoints

  • Incidence of adverse events
  • Change from baseline in blood pressure and temperature around the clamp

Results so far

No results. Recruiting; estimated n=25; actual start 10 February 2026; estimated primary completion September 2026. Last registry update 28 April 2026. A single-bolus clamp is not a closed-loop intraperitoneal pump result.

The full picture

Intraperitoneal insulin is absorbed into the portal vein, so it can act faster than a subcutaneous injection and more like pancreatic insulin. Portal Diabetes is testing its own U-500 formulation as a single bolus under clamp conditions, not as a wearable pump in daily life.

The clamp holds glucose steady with a variable glucose infusion after the dose. That answers PK/PD and short-term safety. It does not answer whether an intraperitoneal pump would improve time in 70–180 mg/dL (3.9–10.0 mmol/L) at home. No ranked insulin item is added on a 25-person clamp alone.