Actively Recruiting
A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500
Led by Portal Diabetes, Inc. · Updated on 2026-04-28
25
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 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 with plasma glucose above 90 mg/dL
- HbA1c concentration of 8.5% or less
- Body mass index between 18.5 and 30.0 kg/m2
- Weight of 50 kg or more
- Female participants must be non-pregnant, non-lactating, and postmenopausal confirmed by hormone testing
- Male participants must be surgically sterile, abstinent, or use acceptable contraception if of childbearing potential
- Have sufficient venous access for blood sampling
- Able to give informed consent and willing to follow study procedures
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 diabetic ketoacidosis or hospitalizations for uncontrolled diabetes within 6 months
- Unable to avoid major dietary changes during the study
- Systolic blood pressure above 150 mm Hg or diastolic blood pressure above 90 mm Hg unless treated with stable doses of no more than two antihypertensive medications for at least 3 months
- Current use of prohibited medications
- Major surgery within 6 months prior to screening
- Serious allergic reactions or hypersensitivity to study product components
- Renal disease or abnormal kidney function with estimated GFR below 60 mL/min/1.73m2
- Triglycerides above 500 mg/dL
- Significant abnormal hematology or biochemistry tests
- History of heart disease including symptomatic heart failure, myocardial infarction, or related conditions
- Abnormal physical, laboratory, or ECG findings that may interfere with study conduct
- History or presence of malignant neoplasms within 5 years except certain skin cancers
- Clinically significant concomitant diseases judged by investigator
- Personal or family history of clotting or thromboembolic diseases
- Active infection or recent mild viral illness within 30 days
- Vaccinations within 2 weeks prior to clinic admission
- History of alcohol or drug abuse within about 1 year or positive tests at screening
- Smoking more than 5 cigarettes daily or unwillingness to stop smoking during inpatient period
- Positive tests for hepatitis B, hepatitis C, or HIV at screening
- Medical or surgical conditions interfering with drug absorption or safety assessments
- Mental disorders or poor treatment adherence judged by investigator
- Participation in another investigational study within 30 days or 5 half-lives of last study drug dose
- Blood donation or loss of more than 500 mL within 56 days prior to screening
- Poor venous access as judged by study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here