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The present study aimed to evaluate the pharmacokinetic and pharmacodynamic properties of insulin degludec ( ID eg) in Japanese patients with type 1 diabetes.    Materials and Methods  This was a randomized, single‐center, double‐blind, two‐period, crossover, multiple‐dose trial. Patients were randomized into two treatment sequences, and received  ID eg or insulin detemir for 6 days and a washout period (7–21 days) before switching treatment. Blood samples for pharmacokinetic measurements were obtained before each dose and up to 120 h after the last dose of each treatment period. Pharmacodynamic measurements were obtained using a 26‐h euglycemic clamp procedure after the last dose of each treatment period.    Results  A total of 22 patients were randomized (14 men, 8 women; mean glycosylated hemoglobin at baseline of 7.5% [based on Japanese Diabetes Society value]). At steady state, total glucose‐lowering effect (area under the glucose infusion rate [ GIR ] curve during one dosing interval [τ, 0–24 h] at steady state [ AUC GIR   ,τ,   SS  ]) was 1,446 mg/kg and total exposure (geometric mean) of  ID eg ( AUC ID   eg,τ,   SS  ) was 81,270 pmol h/L. Both the glucose‐lowering effect and the exposure of  ID eg were evenly distributed over the dosing interval, with  AUC  for the first 12‐h intervals being approximately 50% of the total (geometric mean;  AUC GIR   ,0–12h,   SS  / AUC GIR   ,τ,   SS   = 48%;  AUC ID   eg,0–12h,   SS  / AUC ID   eg,τ,   SS   = 53%).    Conclusions   ID eg has a flat, consistent and ultra‐long glucose‐lowering effect that is evenly distributed across a 24‐h interval and an ultra‐long duration of action in Japanese patients with type 1 diabetes. These data support once‐daily dosing of  ID eg in all patients. Overall, the pharmacodynamic and pharmacokinetic end‐points and safety observations are consistent with those previously reported in Caucasian patients.

journal of diabetes investigation

Pharmacokinetic and pharmacodynamic properties of insulin degludec in Japanese patients with type 1 diabetes mellitus reflect similarities with Caucasian patients