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A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics and Glucodynamics of Intraperitoneal Portal Insulin U-500
Led by Portal Diabetes, Inc. · Updated on 2026-04-28
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, absorption speed, and action duration of a new U500 insulin formulation given into the abdominal cavity (intraperitoneally) in adults with Type 1 Diabetes. The study compares this investigational insulin (PI-U500) with two existing insulins: Humulin R U500 given intraperitoneally and Lyumjev U100 given under the skin (subcutaneously). The trial aims to answer key questions about how well the new insulin is tolerated and how it behaves in the body. Participants receive single doses of insulin at different strengths (0.1, 0.2, or 0.3 units per kilogram) administered intraperitoneally or subcutaneously depending on the study group. The study uses a randomized, crossover design where participants receive different insulin types in varying orders. Several dosing sequences and combinations are tested to evaluate safety and how quickly and effectively the insulin works. The insulin doses are given during a controlled 12-hour procedure called a euglycemic clamp. During the 12-hour clamp, participants' blood glucose levels are kept steady by adjusting glucose infusion rates. Researchers monitor safety through vital signs, blood tests, and physical exams before and after insulin administration. They also measure insulin levels and glucose use over time to assess pharmacokinetics and glucodynamics. Pain and inflammation markers are evaluated shortly after dosing. Participants are followed for about two months to record any adverse events. The study includes multiple visits and careful monitoring to understand how the new insulin behaves and is tolerated.
CONDITIONS
Brief Title
A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years at the time of informed consent
- Diagnosed with Type 1 Diabetes for at least 12 months
- Using an approved insulin pump or stable multiple daily injections for at least 3 months
- Fasting C-peptide concentration of 0.3 nmol/L or less when plasma glucose is above 90 mg/dL
- HbA1c level of 8.5% or less
- Body mass index (BMI) between 18.5 and 30.0 kg/m2
- Weight of at least 50 kg
- Female participants must be non-pregnant, non-lactating, and postmenopausal confirmed by testing
- Male participants must be surgically sterile, abstinent, or use acceptable contraception if of child-bearing potential
- Have sufficient venous access for blood sampling
- Able to give informed consent and willing to follow study procedures and duration
You will not qualify if you...
- Proliferative retinopathy, maculopathy, severe gastroparesis, or severe neuropathy including autonomic neuropathy
- History of two or more severe hypoglycemia episodes or one or more diabetic ketoacidosis episodes or hospitalizations within 6 months prior to screening
- Unable to avoid major dietary changes during the study
- High blood pressure above 150/90 mm Hg; stable treatment with up to two antihypertensive drugs required
- Use of prohibited medications
- Major surgery within 6 months prior to screening
- History of serious allergic reactions to study product components
- Kidney disease or abnormal kidney function with GFR below 60 mL/min/1.73m2
- Triglycerides above 500 mg/dL
- Significant abnormal blood or chemistry tests
- History of serious heart disease including heart failure, heart attack, or stroke
- Abnormal ECG or physical exam findings that may interfere with study
- Cancer history within 5 years except certain skin cancers
- Significant other diseases judged by investigator
- History or family history of blood clotting disorders
- Recent infections or vaccinations
- History of alcohol or drug abuse within approximately 1 year
- Smoking more than 5 cigarettes daily or unwillingness to refrain during study
- Positive tests for hepatitis B, hepatitis C, or HIV
- Conditions interfering with drug absorption or safety measurements
- Mental health or adherence issues affecting study participation
- Participation in other investigational studies recently
- Recent blood donation or loss above 500 mL
- Poor venous access as judged by study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment lasts 12 hours; multiple dosing sessions with crossover design
Participants will receive single doses of insulin via intraperitoneal or subcutaneous delivery during a 12-hour euglycemic clamp to study safety and pharmacokinetics.
Multiple dosing visits depending on assigned group and crossover schedule
Duration - Approximately 2 months
Participants are monitored for safety and adverse events for an average of 2 months after the last treatment dose.
Follow-up visits as scheduled during the 2-month monitoring period
Trial Site Locations
Total: 1 location
1
ProSciento, Inc.
Chula Vista, California, United States, 91911
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
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