Portal Insulin U-500 for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new insulin formulation, Portal Insulin U-500, to determine its safety and speed of action for people with Type 1 Diabetes. Researchers will compare the new insulin, administered directly into the abdomen (intraperitoneally), with other insulin types to assess which acts faster and lasts longer. Participants must have had Type 1 Diabetes for at least a year and regularly use an insulin pump or injections. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new insulin formulation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Humulin R U-500, a concentrated insulin, is generally safe for people with diabetes who require large doses. Studies indicate that Humulin R U-500 helps control blood sugar levels in both adults and children with diabetes. It is important to remember that this insulin is much stronger than regular insulin, so using the correct dose is crucial.
Limited specific information exists on Portal Insulin U-500 (PI-U500) because it remains in early testing. Since this trial is in its first phase, researchers focus primarily on ensuring the treatment's safety. Early trials like this usually involve small groups and aim to find the best dose while checking for any side effects.
The trial compares PI-U500 with Humulin R U-500 and another insulin called Lyumjev. Both Humulin R U-500 and Lyumjev have been approved for use, suggesting they are safe when used correctly. Participants in the trial will receive different doses of PI-U500 to observe how their bodies respond.
In summary, while PI-U500 is still being tested, the use of other approved insulins in the trial provides some reassurance about the safety of similar treatments.12345Why are researchers excited about this trial's treatments?
Portal Insulin U-500 is unique because it involves delivering insulin directly into the abdominal cavity, a method known as intraperitoneal administration. This is different from the usual subcutaneous injections used in standard treatments like Humulin R or Lyumjev. Researchers are excited about this approach because it might offer more rapid and consistent insulin absorption, potentially leading to better blood glucose control for people with Type 1 diabetes. This could mean fewer high and low blood sugar swings, improving overall quality of life.
What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?
Research shows that U-500 insulin can greatly help people with insulin resistance by improving blood sugar control. Studies have found that U-500 effectively stabilizes blood sugar levels in patients unresponsive to regular insulin doses. In this trial, participants will receive Portal Insulin U-500, tested by direct injection into the abdominal cavity. This method might alter the insulin's onset of action. Early results suggest this could be a promising way to manage blood sugar levels in people with Type 1 Diabetes.16789
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with Type 1 Diabetes, using an insulin pump or multiple daily injections for at least 3 months. They must have low C-peptide levels, controlled HbA1c (≤8.5%), a BMI of 18.5-30 kg/m2, and weigh over 50 kg. Women should be non-pregnant, non-lactating, postmenopausal; men need to use contraception if not sterile.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 12-hour euglycemic clamp procedure with intraperitoneal insulin administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Portal Insulin U-500
Trial Overview
The study tests the safety and effectiveness of a new U500 insulin given intraperitoneally compared to Humulin R U500 also given intraperitoneally and Lyumjev U100 administered subcutaneously in people with Type 1 Diabetes during a controlled blood glucose procedure lasting for 12 hours.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
A three-way crossover where participants will receive 0.2 U/kg of each of the drugs sequentially, but the order will be randomized into three options: * Option 1: 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally, and finally 0.2 U/kg of PI-U500 intraperitoneally. * Option 2: 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally , followed by 0.2 U/kg of PI-U500 intraperitoneally, and finally 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously. * Option 3: 0.2 U/kg of PI-U500 intraperitoneally , followed by 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, and finally 0.2 U/kg of Humulin R U500 (Active Control) intraperitoneally.
A two-way crossover where participants will receive 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of PI-U500 intraperitoneally.
A three-way crossover where participants will receive 0.2 U/kg of Lyumjev U-100 (Active Control) subcutaneously, followed by 0.2 U/kg of PI-U500 intraperitoneally, and finally 0.3 U/kg of PI-U500, also intraperitoneally.
A three-way crossover where participants will receive 0.1 U/kg of PI-U500, followed by 0.2 U/kg of Humulin R U500 (Active Control), and finally 0.3 U/kg of PI-U500. All administered intraperitoneally.
A three-way crossover where participants will receive 0.1 U/kg of PI-U500, followed by 0.2 U/kg of Humulin R U500 (Active Control), and finally 0.2 U/kg of PI-U500. All administered intraperitoneally.
Participants will receive PI-U500 intraperitoneally at 0.1 U/kg, then 0.2 U/kg and lastly 0.3 U/kg
Find a Clinic Near You
Who Is Running the Clinical Trial?
Portal Diabetes, Inc.
Lead Sponsor
Citations
A Single Bolus, 12-hour Euglycemic Clamp Study of the ...
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 ...
Clinical Use of U-500 Regular Insulin: Review and Meta ...
The use of U-500 regular insulin (U-500R) to treat diabetic patients with severe insulin resistance has increased.
Clinical Efficacy and Patient Satisfaction with U-500 Insulin ...
We performed a retrospective review of medical records of 6 patients with type 2 diabetes and insulin resistance who had been using U-500 insulin pump ...
Analysis of Effectiveness of Human U-500 Insulin in ...
U-500 insulin therapy yields improved glycemic control in insulin-resistant patients who have poor control of blood glucose with use of standard insulin ...
5.
diabetesjournals.org
diabetesjournals.org/clinical/article/33/1/14/31268/Evaluating-the-Effect-of-U-500-Insulin-Therapy-onEvaluating the Effect of U-500 Insulin Therapy on Glycemic ...
IN BRIEF This article describes a single-center, retrospective chart review to determine the glycemic effect of converting from U-100 to ...
humulin-r-u500-pi.pdf
The safety and effectiveness of HUMULIN R U-500 in pediatric patients with diabetes mellitus requiring more than. 200 units of insulin per day to improve ...
HUMULIN R U-500 (insulin human injection), for ...
HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than ...
8.
patientsafetyj.com
patientsafetyj.com/article/144287-strategies-to-prevent-five-fold-wrong-dose-errors-with-u-500-insulin.pdfStrategies to Prevent Fivefold Wrong Dose Errors With U-500 ...
Humulin R U-500, a type of insulin that is five times more ... Addressing Safety Concerns About U-500 Insulin in a Hospital Setting.
Safety Brief: U-500 insulin
Background. High concentration insulin (500 units/mL; trade name Humulin R U-500) is five times the strength of all other insulin.
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