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Fast‐acting insulin aspart (faster aspart) is insulin aspart ( IA sp) in a new formulation with two added excipients (niacinamide and L‐arginine) in order to obtain accelerated absorption after subcutaneous dosing. The present study compared the pharmacokinetic/pharmacodynamic characteristics of faster aspart vs  IA sp in Japanese patients with type 1 diabetes.    Materials and Methods  In a randomized, double‐blind, cross‐over design, 43 participants were given faster aspart and  IA sp (0.2 U/kg single dose) at two separate dosing visits. Frequent pharmacokinetic blood sampling was carried out, and pharmacodynamics were assessed using an automated euglycemic clamp lasting for a maximum of 12 h after dosing (target 5.5 mmol/L).    Results  Faster aspart showed onset of appearance approximately twice‐as‐fast vs  IA sp (least squares means: 3.0 vs 7.1 min; estimated treatment difference −4.1 min, 95% confidence interval [CI]: −5.0, −3.2;  P  < 0.001) and onset of action occurring approximately 5 min earlier (20.2 vs 25.5 min; estimated treatment difference −5.3 min, 95% CI: −8.4, −2.2;  P  = 0.001). Within the first 30 min post‐dose, both exposure (area under the curve [ AUC ]  IA   sp,0–30 min ) and glucose‐lowering effect ( AUC GIR   ,0–30 min ) were approximately twofold greater for faster aspart vs  IA sp ( P  < 0.001 and  P  = 0.002, respectively). Bioavailability of faster aspart was similar to  IA sp ( AUC IA   sp,0‐t ; estimated treatment ratio 0.99, 90% CI: 0.96–1.02), whereas the total glucose‐lowering effect ( AUC GIR   ,0–t ) was slightly lower for faster aspart vs  IA sp (estimated treatment ratio 0.93, 95% CI: 0.87–0.99,  P  = 0.020).    Conclusions  Faster aspart showed faster onset, higher early exposure and a greater early glucose‐lowering effect relative to  IA sp in Japanese patients with type 1 diabetes, in accordance with previous findings in Caucasian type 1 diabetes patients.

journal of diabetes investigation

Fast‐acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose‐lowering effect relative to insulin aspart