RecruitingPhase 1

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

United States25 participantsStarted 2026-02-10

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. Fasting C-peptide concentration of ≤0.3 nmol/L (0.9061 ng/ml), assessed at a plasma glucose concentration \>90 mg/dL. (If necessary, the subject may consume carbohydrates to raise BG over 90 mg/dL as measured by YSI (glucose analyzer) prior to drawing blood for C-peptide. This may be repeated as needed to ensure C-peptide is assessed when plasma glucose concentration is \>90 mg/dL).
✓. HbA1c concentration of ≤8.5%.
✓. Body mass index (BMI) within the range ≥18.5 to ≤30.0 kg/m2.
✓. Weight ≥ 50 kg.
✓. Female subjects must be non-pregnant and non-lactating and postmenopausal (no menses \>12 months); postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels at Screening for all female subjects.

Exclusion criteria

What they're measuring

Safety: Incidence of adverse events

Timeframe: From enrollment until the follow-up visit, an average of 2 months

Safety: Change from baseline in systolic and diastolic blood pressure

Timeframe: Will 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 temperature

Timeframe: Will 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 rate

Timeframe: Will 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 rate

Timeframe: Will 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) parameters

Timeframe: Pre-dose and after the end of PK-sampling (720 minutes post-dose)

Trial details

NCT IDNCT07341373

SponsorPortal Diabetes, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Type 1 Diabetes trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. Fasting C-peptide concentration of ≤0.3 nmol/L (0.9061 ng/ml), assessed at a plasma glucose concentration \>90 mg/dL. (If necessary, the subject may consume carbohydrates to raise BG over 90 mg/dL as measured by YSI (glucose analyzer) prior to drawing blood for C-peptide. This may be repeated as needed to ensure C-peptide is assessed when plasma glucose concentration is \>90 mg/dL).
✓. HbA1c concentration of ≤8.5%.
✓. Body mass index (BMI) within the range ≥18.5 to ≤30.0 kg/m2.
✓. Weight ≥ 50 kg.
✓. Female subjects must be non-pregnant and non-lactating and postmenopausal (no menses \>12 months); postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels at Screening for all female subjects.

Exclusion criteria

What they're measuring

Safety: Incidence of adverse events

Timeframe: From enrollment until the follow-up visit, an average of 2 months

Safety: Change from baseline in systolic and diastolic blood pressure

Timeframe: Will 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 temperature

Timeframe: Will 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 rate

Timeframe: Will 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 rate

Timeframe: Will 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) parameters

Timeframe: Pre-dose and after the end of PK-sampling (720 minutes post-dose)