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Pieber, TR; Svehlikova, E; Brunner, M; Halberg, IB; Due Thomsen, KM; Haahr, H.
Fast-acting insulin aspart in people with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart.
Diabetes Obes Metab. 2019; 21(9):2068-2075 Doi: 10.1111/dom.13767 [OPEN ACCESS]
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Leading authors Med Uni Graz: Pieber Thomas
Co-authors Med Uni Graz: Brunner Martina; Svehlikova Eva
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Abstract:: To investigate the pharmacokinetic/pharmacodynamic properties of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) in people with type 2 diabetes (T2D). In a randomized, double-blind, crossover design, 61 people with T2D usually treated with insulin ± oral antidiabetic drug(s) received single-dose faster aspart and IAsp (0.3 U/kg) on separate visits. Blood samples for pharmacokinetic assessment were collected frequently until 12 hours post-dose. Glucose-lowering effect was determined in a euglycaemic clamp lasting up to 12 hours post-dose (target 5.0 mmol/L). The serum IAsp pharmacokinetic profile and glucose-lowering effect profile were shifted to the left for faster aspart versus IAsp. Least squares mean (± SE) onset of appearance was 3.3 ± 0.3 minutes for faster aspart, which was 1.2 minutes earlier than for IAsp (95% confidence interval [CI] -1.8;-0.5; P = .001). Onset of action for faster aspart was 8.9 minutes earlier (95% CI -12.1;-5.7; P < .001) than for IAsp. During the first 30 minutes after dosing, 89% larger IAsp exposure (ratio faster aspart/IAsp 1.89 [95% CI 1.56;2.28]; P < .001) and 147% greater glucose-lowering effect (2.47 [95% CI 1.58;6.22]; P < .001) were observed for faster aspart compared with IAsp. Offset of exposure (time to 50% of maximum IAsp concentration in the late part of the pharmacokinetic profile) occurred earlier for faster aspart (difference faster aspart - IAsp -36.4 minutes [95% CI -55.3;-17.6]; P < .001). The treatment difference of faster aspart - IAsp in offset of glucose-lowering effect (time to 50% of maximum glucose infusion rate in the late part of the glucose infusion rate profile) was -14.4 minutes (95% CI -34.4;5.5; P = .152). In people with T2D, faster aspart was associated with earlier onset and greater initial exposure and glucose-lowering effect compared with IAsp, as previously shown in people with type 1 diabetes. © 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Find related publications in this database (Keywords): clinical trial; insulin therapy; pharmacodynamics; pharmacokinetics; phase I-II study; type 2 diabetes