Open AccessInsulin degludec/insulin aspart in Japanese patients with type 1 diabetes mellitus: Distinct prandial and basal glucose‐lowering effects
Author(s) -
Haahr Hanne,
Sasaki Tomio,
Bardtrum Lars,
Ikushima Ippei
Publication year - 2016
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12461
Subject(s) - insulin aspart , medicine , pharmacodynamics , endocrinology , insulin , insulin degludec , diabetes mellitus , type 2 diabetes mellitus , basal (medicine) , dosing , type 1 diabetes , crossover study , bolus (digestion) , onset of action , type 2 diabetes , basal insulin , pharmacokinetics , placebo , alternative medicine , pathology
Aims/Introduction Insulin degludec/insulin aspart ( ID egAsp) is a soluble co‐formulation of long‐acting insulin degludec ( ID eg) and rapid‐acting insulin aspart ( IA sp). The present study investigated the pharmacodynamic properties of ID egAsp in Japanese patients with type 1 diabetes mellitus. Materials and Methods In this randomized, double‐blind, two‐period, cross‐over trial, 21 Japanese patients with type 1 diabetes mellitus received single doses of 0.5 U/kg ID egAsp and biphasic insulin aspart 30 in a randomized sequence (13–21 days washout between treatments). The pharmacodynamic response was evaluated in a 26‐h euglycemic glucose clamp (target 5.5 mmol/L). Single‐dose ID egAsp glucose infusion rate ( GIR ) profiles were extrapolated to steady state using modeling. Results The ID egAsp single‐dose GIR profile showed a clear distinction between the effects of the bolus ( IA sp) and basal ( ID eg) components in ID egAsp. When simulated to steady state, the GIR profile of ID egAsp was shifted upwards compared with the single‐dose profile, and showed a rapid onset of action and a distinct peak from the IA sp component followed by a separate and sustained basal action from the long‐acting ID eg component. For biphasic insulin aspart 30, the initial shape of the GIR profile was similar to ID egAsp, but GIR continuously decreased from maximum and reached zero 18–20 h post‐dosing. The characteristics of the GIR profile for ID egAsp were retained when simulated to steady state in a twice‐daily dosing regimen. Discussion In Japanese patients with type 1 diabetes mellitus, the pharmacodynamic profile of ID egAsp is characterized by distinct prandial and basal effects from the IA sp and ID eg components, consistent with what has been reported previously in Caucasian patients with type 1 diabetes mellitus.