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Tests treatment safety and results for Type 1 Diabetes
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
ClinicalTrials.gov ID: NCT07341373
What this study is testing
What is Portal Insulin U-500?
Portal Insulin U-500 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type 1 diabetes.
Also referred to as PI-U500.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- people who meet all the following criteria at Screening will be included in the study:
- people ≥18 to ≤60 years of age at the time of signing the informed consent.
- people diagnosed with T1DM for at least 12 months.
- people 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...
You likely can't join if
- people who meet any of the following criteria will be excluded from participating in the study:
- A subject who has proliferative retinopathy or maculopathy (based on records/documentation of ophthalmologic exam within 18 months of Screening or...
- History of ≥2 episodes of severe hypoglycemia (as defined per ADA criteria) or ≥1 episodes of diabetic ketoacidosis or emergency room visits for...
- Subject is not able to avoid major dietary changes for the duration of the study.
- Systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \>90 mm Hg at Screening. Treatment with no more than 2 antihypertensive...
- Current use of any drugs as listed in the table of prohibited medications.
See the full eligibility criteria
- people who meet all the following criteria at Screening will be included in the study:
- people ≥18 to ≤60 years of age at the time of signing the informed consent.
- people diagnosed with T1DM for at least 12 months.
- people 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...
- HbA1c concentration of ≤8.5%.
- Body mass index (BMI) within the range ≥18.5 to ≤30.0 kg/m2.
- Weight ≥ 50 kg.
- Female people 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...
- Male people must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject and his partner must be using acceptable methods of contraception.
- Has venous access sufficient to allow for blood sampling.
- Capable of giving signed informed consent and willing to follow study procedures and commitment to the study duration.
- people who meet any of the following criteria will be excluded from participating in the study:
- A subject who has proliferative retinopathy or maculopathy (based on records/documentation of ophthalmologic exam within 18 months of Screening or ophthalmologic exam during Screening), severe gastroparesis, and/or...
- History of ≥2 episodes of severe hypoglycemia (as defined per ADA criteria) or ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to...
- Subject is not able to avoid major dietary changes for the duration of the study.
- Systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \>90 mm Hg at Screening. Treatment with no more than 2 antihypertensive medications must be with stable doses for at least 3 months prior to Screening.
- Current use of any drugs as listed in the table of prohibited medications.
- History of any major surgery within 6 months prior to Screening.
- History of any serious allergic adverse reaction or hypersensitivity to any of the product components.
- History of renal disease or abnormal kidney function tests at Screening (GFR \<60 mL/min/1.73m2 as estimated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]).
- Triglycerides \>500 mg/dL at Screening.
- Clinically significant abnormal hematology or biochemistry screening tests. people may have these labs be redrawn once on a separate day.
- Any history of heart disease, defined as symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, coronary artery bypass graft surgery, or angioplasty, unstable angina requiring...
- Presence of clinically significant physical, laboratory, or ECG findings (eg, QTcF \>450 msec for males, QTcF \>470 msec for females) at Screening that, in the opinion of the Investigator, may interfere with any aspect...
- History or presence of malignant neoplasms within the past 5 years prior to the day of Screening. Basal and squamous cell skin cancer and any in-situ carcinomas are allowed.
- Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by...
- Personal or family history of hypercoagulability or thromboembolic disease.
- History of any active infection, other than mild viral illness within 30 days prior to dosing as judged by the Investigator.
- Administration of any vaccinations in the 2 weeks prior to admission to the clinic.
- History of alcohol abuse as judged by the Investigator within approximately 1 year or consuming \>2 standard drinks on average per day in men, and \>1 standard drinks on average per day in women, and/or positive alcohol...
- History of illicit/recreational drug abuse within approximately 1 year as judged by the Investigator. Frequent use of marijuana or other tetrahydrocannabinol (THC) products within 6 weeks, or clinically under the effect...
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); or non- or occasional smoker who is not able or willing to refrain from smoking and use of nicotine gum or transdermal...
- Known history or positive test of hepatitis B surface antigen (HBsAg), hepatitis C antibody test (anti-HCV), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody at Screening.
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution or metabolism of the drugs or the side effects/safety measurements.
- Any subject who, per the opinion of the Investigator, will not make a good study subject relative to mental disorder, history of poor treatment adherence, etc.
- Participation in an investigational study within 30 days prior to dosing or within 5 half-lives of the last dose of study drug whichever is longer.
- Donation or loss of \>500 mL of blood or blood product within 56 days of Screening.
- Poor venous access as judged by the study team.
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.