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

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human) and Insulin Lispro.

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.

It had six arms (groups): one (experimental), Part B, Group 2 (other), Part B, Group 3 (other), Part B, Group 4 (other) and Part B, Group 5 (other).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 25 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects who meet all the following criteria at Screening will be included in the study:. Subjects ≥18 to ≤60 years of age at the time of signing the informed consent. Subjects diagnosed with T1DM for at least 12 months. Subjects who have been using an approved insulin pump or use MDI with basal and bolus insulin (stable use for 3 months). Body mass index (BMI) within the range ≥18.5 to ≤30.0 kg/m2.

The full record lists 12 inclusion and 27 exclusion criteria; among the exclusions: subjects who meet any of the following criteria will be excluded from participating in the study:; subject is not able to avoid major dietary changes for the duration of the study; current use of any drugs as listed in the table of prohibited medications.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-02-10 with completion listed for 2026-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety: Incidence of adverse events (time frame: From enrollment until the follow-up visit, an average of 2 months). Safety: Change from baseline in systolic and diastolic blood pressure. Safety: Change from baseline in temperature.

It also tracked 7 secondary outcomes, for example Glucodynamic: Area under GIR time curve in time intervals.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Insulin Lispro in 25 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Insulin Lispro compound page, all human trials.