Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Heise, T; Korsatko, S; Nosek, L; Coester, HV; Deller, S; Roepstorff, C; Segel, S; Kapur, R; Haahr, H; Hompesch, M.
Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action.
J Diabetes. 2016; 8(1):132-138
Doi: 10.1111/1753-0407.12266
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
- Deller Sigrid
- Korsatko Stefan
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- Abstract:
- 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. 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. 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). 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. © 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- African Americans -
- Aged -
- Area Under Curve -
- Blood Glucose - drug effects
- Diabetes Mellitus, Type 1 - drug therapy
- Diabetes Mellitus, Type 1 - ethnology
- Diabetes Mellitus, Type 1 - metabolism
- Diabetes Mellitus, Type 2 - drug therapy
- Diabetes Mellitus, Type 2 - ethnology
- Diabetes Mellitus, Type 2 - metabolism
- Double-Blind Method -
- Drug Administration Schedule -
- Female -
- Hispanic Americans -
- Humans -
- Hypoglycemic Agents - administration & dosage
- Hypoglycemic Agents - pharmacokinetics
- Injections, Subcutaneous -
- Insulin, Long-Acting - administration & dosage
- Insulin, Long-Acting - pharmacokinetics
- Male -
- Middle Aged -
- Time Factors -
- Young Adult -
- Find related publications in this database (Keywords)
- basal insulin
- diabetes
- pharmacokinetics
- steady state