Pharmacokinetics and Pharmacodynamics of Human Regular U-500 Insulin Administered via Continuous Subcutaneous Insulin Infusion vs. Subcutaneous Injection in Adults with Type 2 Diabetes and High Insulin Requirements

Abstract

There have been no euglycemic clamp studies on U-500R in obese patients with type 2 diabetes (T2DM) and high insulin requirements. This open-label, randomized, 2-way crossover, euglycemic clamp study evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of U-500R administered by continuous subcutaneous insulin infusion (CSII; using an investigational Omnipod® U-500 Insulin Management System) compared to subcutaneous injection (SCI) (using a U-100 syringe), in adults with T2DM requiring >150 U/day of insulin.