Open AccessSteady state is reached within 2–3 days of once‐daily administration of degludec, a basal insulin with an ultralong duration of action
Author(s) -
Heise Tim,
Korsatko Stefan,
Nosek Leszek,
Coester Hans Veit,
Deller Sigrid,
Roepstorff Carsten,
Segel Stine,
Kapur Rahul,
Haahr Hanne,
Hompesch Marcus
Publication year - 2016
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.12266
Subject(s) - insulin degludec , medicine , diabetes mellitus , insulin , pharmacokinetics , basal (medicine) , pharmacodynamics , endocrinology , type 1 diabetes , steady state (chemistry) , type 2 diabetes , basal insulin , chemistry
Background Various factors influence the pharmacokinetic and pharmacodynamic properties of insulin analogs. The aim of the present study was to determine time to steady state of insulin degludec ( IDeg ), a basal insulin analog with an ultralong duration of action, after once‐daily subcutaneous administration in subjects of varying age, diabetes type, and ethnicity. Methods Time to steady state was analyzed in 195 subjects across five Phase I randomized single‐center double‐blind studies: three in subjects with type 1 diabetes ( T1DM ), including one in elderly subjects, and two in subjects with type 2 diabetes ( T2DM ), including one with A frican A merican and H ispanic/ L atino subpopulations. Subjects received once‐daily IDeg (100 U /mL, s.c.) at doses of 0.4–0.8 U /kg for 6–12 days. Time to clinical steady state was measured from first dose until the serum IDeg trough concentration exceeded 90% of the final plateau level. The IDeg concentrations were log‐transformed and analyzed using a mixed‐effects model with time from first dose and dose level (where applicable) as fixed effects, and subject as a random effect. Results Steady state serum IDeg concentrations were reached after 2–3 days in all subjects. In trials with multiple dose levels, time to steady state was independent of dose level in T1DM ( P = 0.51) and T2DM ( P = 0.75). Conclusions Serum IDeg concentrations reached steady state within 2–3 days of once‐daily subcutaneous administration in all subjects with T1DM or T2DM , including elderly and A frican A merican and H ispanic/ L atino subjects. At steady state, serum IDeg concentrations were unchanged from day to day.