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Brunner, M; Pieber, T; Korsatko, S; Kojzar, H; Svendsen, AL; Haahr, H.
The Distinct Prandial and Basal Pharmacodynamics of IDegAsp Observed in Younger Adults Are Preserved in Elderly Subjects with Type 1 Diabetes.
Drugs Aging. 2015; 32(7):583-590 Doi: 10.1007/s40266-015-0272-y [OPEN ACCESS]
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Leading authors Med Uni Graz: Brunner Martina
Co-authors Med Uni Graz: Kojzar Harald; Korsatko Stefan; Pieber Thomas
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Abstract:: Management of diabetes in elderly patients is complicated by the elevated risk of insulin-induced hypoglycaemia. This is the first study to report the pharmacodynamic and pharmacokinetic characteristics of IDegAsp (insulin degludec [IDeg]/insulin aspart [IAsp]), a soluble co-formulation of a long-acting basal insulin analogue (IDeg) and a rapid-acting insulin analogue (IAsp) in a single injection, in elderly and younger adult subjects with type 1 diabetes using a glucose clamp. In this randomised, single-centre, double-blind, single-dose (SD), two-period, crossover trial, 15 elderly subjects (aged ≥ 65 years) and 13 younger adults (aged 18-35 years) with type 1 diabetes were randomly assigned to two SD administrations of 0.5 U/kg IDegAsp or biphasic insulin aspart 30 (control) followed by a 26-h euglycaemic glucose clamp and 120-h pharmacokinetic blood sampling. The glucose infusion rate (GIR) profiles were extrapolated to simulated steady-state (SS) conditions using pharmacodynamic models. IDegAsp GIR profiles showed a distinct peak and rapid onset of action from IAsp followed by a separate and flat basal action from IDeg. Mean 24-h area under the GIR curve was similar in elderly subjects vs. younger adults (mean ratio 1.01 [95% confidence interval 0.69-1.47]). Simulated SS pharmacodynamic profiles with once-daily IDegAsp showed a parallel upshift in GIR profiles vs. SD profiles. The shape of the IDegAsp pharmacodynamic profile was retained with twice-daily dosing under simulated SS conditions. IDegAsp was well tolerated. The distinct prandial and basal pharmacodynamics of IDegAsp observed in younger adults were preserved in elderly subjects with type 1 diabetes. The glucose-lowering effect of IDegAsp was similar in elderly subjects and younger adults with type 1 diabetes.
Find related publications in this database (using NLM MeSH Indexing): Adult -; Age Factors -; Aged -; Cross-Over Studies -; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Disease Management -; Double-Blind Method -; Drug Combinations -; Female -; Glucose Clamp Technique -; Humans -; Hypoglycemic Agents - blood; Hypoglycemic Agents - therapeutic use; Insulin, Long-Acting - blood; Insulin, Long-Acting - pharmacokinetics; Insulin, Long-Acting - therapeutic use; Male -; Middle Aged -; Postprandial Period -; Young Adult -