ADO09, a co‐formulation of the amylin‐analog pramlintide and the insulin analog A21G, lowers postprandial blood glucose versus insulin lispro in type 1 diabetes (T1D)

Objective Pramlintide has been shown to improve postprandial Blood Glucose (ppBG) as an adjunct to insulin. So far, pramlintide and insulin have to be injected separately as a co-formulation was not available. ADO09 is a stable co-formulation of pramlintide and an insulin analog formulated at acidic pH. This double-blind, double-dummy, randomised, cross-over meal test trial compared the safety, pharmacokinetics and pharmacodynamics of ADO09 with insulin lispro (lispro) and separate subcutaneous injections of human insulin and pramlintide (InsP insulin and pramlintide concentrations were analysed as PK endpoints, and safety and tolerability were assessed. Results Compared with lispro, ADO09 reduced ppBG excursions by more than 95% in the first hour post-meal (mean±SD ∆AUC BG 0-1h: 1.4±9.9 mg*h/dL vs 43.5±15.3 mg*h/dL p Conclusion ADO09 was well tolerated and markedly reduced ppBG compared to Lispro. ADO09 formulation was generally similar to the separate administration of insulin and pramlintide, except a better blood glucose level in the 4-8h interval postmeal. These positive results warrant further investigations with ADO09. This article is protected by copyright. All rights reserved.