Study of Safety and Action of Intraperitoneal Portal Insulin U-500 Compared to Humulin R U500 and Lyumjev U100 in Adults with Type 1 Diabetes

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.

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