Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog^® (Lispro) in Patients with Type 2 Diabetes Mellitus: A Phase I Randomised, Crossover Study.

ABSTRACT:

Background and objective

Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the insulin lispro pharmacokinetics and glucodynamics, safety and tolerability of URLi and Humalog^® after a single subcutaneous dose in patients with type 2 diabetes mellitus (T2DM).

Methods

This was a phase I, randomised, two-period, two-treatment, double-blind, crossover study in 38 patients with T2DM. At each dosing visit, patients received either 15 units of URLi or Humalog, followed by a 10 h automated euglycaemic clamp procedure. Serum insulin lispro and blood glucose were measured.

Results

Insulin lispro appeared in the serum 5 min faster

SUBMITTER: Leohr J 

PROVIDER: S-EPMC7716902 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature