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Study of Intraperitoneal Portal Insulin U-500 for Type 1 Diabetes

This study is looking at a new way to give insulin for people with Type 1 Diabetes. We are testing Portal Insulin U-500, given directly into the abdomen (intraperitoneal delivery), to see how safe it is and how quickly it works. We will compare it to Humulin R U-500 given the same way, and Lyumjev U-100 Insulin given under the skin (subcutaneous delivery). We want to understand if Portal Insulin U-500 is safe and well-tolerated, and how fast it gets absorbed and starts to lower blood sugar. About 25 adults with Type 1 Diabetes, aged 18 to 60, who have been using insulin for at least 12 months, can join this study.

Study design
This is an interventional study planning to enroll 25 participants. It will compare different doses of Portal Insulin U-500 with other insulin types.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment until a follow-up visit, which is an average of 2 months after the study drug is given.

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NCT07341373

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

Recruiting
PHASE1Ages 18–60InterventionalTreatment
Portal Diabetes, Inc.
~25 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Portal Insulin U-500Humulin R U-500Lyumjev U-100 Insulin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety: Incidence of adverse events
Measured over From enrollment until the follow-up visit, an average of 2 months
+16 more outcomes measured

Conditions

Type 1 Diabetes

Explore related trials

Type 1 Diabetes MellitusC Peptide

Where it's being run

1 sites across 1 states
California1

Who to contact

Julena Shifter
[email protected]
+16199346286
Email the study team

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Eligibility criteria

Inclusion

Subjects who meet all the following criteria at Screening will be included in the study:

Exclusion

Subjects who meet any of the following criteria will be excluded from participating in the study:

What this trial measures

  • Safety: Incidence of adverse eventsFrom enrollment until the follow-up visit, an average of 2 months
  • Safety: Change from baseline in systolic and diastolic blood pressureWill be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
  • Safety: Change from baseline in temperatureWill be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
  • Safety: Change from baseline in respiratory rateWill be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
  • Safety: Change from baseline in heart rateWill be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)
  • Safety: Change from baseline in 12-lead electrocardiogram (ECG) parametersPre-dose and after the end of PK-sampling (720 minutes post-dose)

    The following parameters will be recorded from the subject's ECG trace as calculated by the machine algorithm: heart rate, QT interval, PR interval, QRS interval, RR interval, and QTc (corrected) using the Fridericia correction (QTcF = QT ÷ cube root of the R-R interval \[where R-R is the duration of the entire cardiac cycle\]).

  • Safety: Incidence and severity of clinical findings on physical examinationPre-dose and after the end of PK-sampling (720 minutes post-dose)
  • Tolerability: Pain assessments per Visual Analogue Scale (VAS)10 min and 1 hour post-dosing

    VAS assessment will target the assessment of abdominal pain. The scale will go from 0 to 10, with 10 being the maximum pain.

  • Tolerability: Change in Interleukin 6 [IL-6] levelsBlood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
  • Tolerability: Change in tumor necrosis factor [TNF-α] levelsBlood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
  • Tolerability: Change in high sensitivity C-reactive protein [hsCRP] levelsBlood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)
  • Pharmacokinetic: Area under the insulin concentration-time curve (AUC)From the time of dose (time 0) until 12 hours post-dose (AUCIns,0-12h)

    For the duration of the euglycemic clamp

  • Pharmacokinetic: Maximum insulin concentration (Cmax)Over 12 hours post-dosing
  • Pharmacokinetic: Time to maximum insulin concentration (Tmax)Over 12 hours post-dosing
  • Glucodynamic: Area under the glucose infusion rate (GIR) time curveFrom the time of dose (time 0) until 12 hours post-dose (AUCGIR,0-12h)
  • Glucodynamic: Maximum GIR (GIRmax)Over 12 hours post-dosing
  • Glucodynamic: Time to maximum GIR (TGIRmax)Over 12 hours post-dosing