2319-PUB: Glycemic Control with XeriSol Regular Insulin and Lispro Insulin: Comparative PK-PD with Humalog and Humulin in STZ Diabetic Rats

Abstract

Insulin therapy is the primary treatment option for patients with type 1 and 2 diabetes. Despite considerable advances in insulin chemistry, delivery, and pharmacology, only a small percentage of diabetic patients achieve near normal glycemic levels. Xeris has developed novel room temperature stable insulin formulations that may offer duration of efficacy advantages over commercially available options. Streptozotocin (65 mg/kg) treated SD rats were given co-formulations of PRAM and Regular Insulin (RI) or Lispro Insulin (LISPRO) as a single injection and compared with dual injection of commercial Symlin, Humulin, or Humalog. Blood samples were evaluated for plasma glucose and PK. A sparse sampling PK scheme resulted in ∼30% CV for glucose values. Mean glucose profiles with reductions in glucose AUC by treatment (efficacy). XeriSol™ insulins showed comparable efficacy and pharmacokinetic profiles commercial products with up to 4 hours of glycemic control. Xerisol formulations of Insulin and Lispro showed trends for lower sustained means (30-240 min) for glucose levels and slightly longer half-lives than comparative doses of commercial Humulin and Humalog. Disclosure S. Thohan: None. M.J. Donovan: None. W.T. Hu: None. M.S. Choi: None. D.M. Hester: None. S.J. Prestrelski: Employee; Self; Xeris Pharmaceuticals, Inc.