NCT07341373

A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Portal Diabetes, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the safety of a new U500 insulin formulation and to determine how rapidly it is absorbed and how long it takes to act when administered intraperitoneally. The trial will be conducted in people with Type 1 Diabetes. The main questions it aims to answer are: Is the drug safe and tolerable when administered intraperitoneally? How fast is it absorbed, and how long does it take to act? Researchers will compare the investigational product (PI-U500) with Humulin R U500 administered intraperitoneally and Lyumjev U100 administered subcutaneously. Participants will undergo a 12-hour clamp procedure in which their blood glucose will be maintained stable via glucose infusion at variable rates after a single intraperitoneal injection of the insulin formulation.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Portal Insulin U-500	Intraperitoneal delivery of a single dose at 0.1 U/kg during an euglycemic clamp
DRUG	Portal Insulin U-500	Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp
DRUG	Portal Insulin U-500	Intraperitoneal delivery of a single dose at 0.3 U/kg during an euglycemic clamp
DRUG	Humulin R U-500	Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp
DRUG	Lyumjev U-100 Insulin	Subcutaneous delivery of a single dose at 0.2 U/kg during an euglycemic clamp

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-01-14
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study