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- Title
Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action 每日1次给予德谷胰岛素(一种持续作用时间超长的基础胰岛素)治疗后在2-3日内可以达到稳态
- Authors
Heise, Tim; Korsatko, Stefan; Nosek, Leszek; Coester, Hans Veit; Deller, Sigrid; Roepstorff, Carsten; Segel, Stine; Kapur, Rahul; Haahr, Hanne; Hompesch, Marcus
- Abstract
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 African American and Hispanic/ Latino 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 African American and Hispanic/ Latino subjects. At steady state, serum IDeg concentrations were unchanged from day to day.
- Subjects
INSULIN therapy; TREATMENT of diabetes; DRUG administration; PHARMACODYNAMICS; PEOPLE with diabetes; MEDICAL care
- Publication
Journal of Diabetes, 2016, Vol 8, Issue 1, p132
- ISSN
1753-0393
- Publication type
Article
- DOI
10.1111/1753-0407.12266