Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of INS068 vs Insulin Degludec in Type 1 Diabetes at Steady State: a Phase I, Randomized, Double-blind, Cross-over Trial

Publication Authors:

M. Hernandez, B. Franey, J. Wang, Y. Li, B. Zhang, M. Hompesch

Presented at the European Association for the Study of Diabetes (EASD) meeting, September 2021.

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Background

Hengrui and ProSciento reported key findings from a clinical study on INS068, a novel long-acting basal insulin analog, at the 2021 European Association for the Study of Diabetes (EASD) meeting. This was a randomized, cross-over phase 1 study to characterize the steady-state pharmacodynamic (PD) and pharmacokinetic (PK) properties as well as safety of INS068 vs IDeg in Type 1 Diabetes Mellitus (T1DM).

Highlights from the Clinical Study

In this single-center, randomized, double-blind, cross-over study, patients with T1DM were randomized to a sequence of two treatment periods with once-daily subcutaneous INS068 or IDeg for nine days at one of three doses (0.4, 0.6 or 0.8 U/kg), separated by a seven to 21-day washout period. Patients at all doses underwent a 42-h euglycemic clamp after the last dose of each treatment period. The primary endpoint was molar dose ratio with INS068 vs IDeg, as assessed by the area under the glucose infusion rate (GIR) time curve during a dosing interval (tau) at SS (AUCGIR,tau,ss).

At doses of 0.4-0.8 U/kg, INS068 demonstrated generally similar PD and PK profiles to IDeg at steady state. The glucose‐lowering effect and exposure of INS068 were dose proportional. INS068 was well-tolerated, with a similar safety profile to IDeg.