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

NCT07341373 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Portal Diabetes, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07341373 on ClinicalTrials.gov