RecruitingPhase 1NCT07341373

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

Sponsor

Portal Diabetes, Inc.

Enrollment

25 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This is a pharmacokinetics study — looking at how a high-concentration intraperitoneal (into the abdomen) insulin called U-500 moves through the body and lowers blood sugar when delivered via an implanted insulin pump. It is designed to establish the safety and drug behaviour profile of this delivery method for people with type 1 diabetes. **You may be eligible if...** - You are 18–60 years old - You have had type 1 diabetes for at least 12 months - You use an insulin pump or multiple daily injections (and have been stable for 3 months) - Your HbA1c is 8.5% or below and your BMI is in the normal to moderate range (18.5–30) - You are postmenopausal (if female) or use effective contraception **You may NOT be eligible if...** - You are pregnant, breastfeeding, or of childbearing potential - You have significant complications or other health conditions that would affect the study results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPortal Insulin U-500

Intraperitoneal delivery of a single dose at 0.1 U/kg during an euglycemic clamp

DRUGPortal Insulin U-500

Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp

DRUGPortal Insulin U-500

Intraperitoneal delivery of a single dose at 0.3 U/kg during an euglycemic clamp

DRUGHumulin R U-500

Intraperitoneal delivery of a single dose at 0.2 U/kg during an euglycemic clamp

DRUGLyumjev U-100 Insulin

Subcutaneous delivery of a single dose at 0.2 U/kg during an euglycemic clamp

Locations(1)

ProSciento, Inc.

Chula Vista, California, United States

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NCT07341373

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