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A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects Type 1 Diabetes Mellitus
Tim Heise, Ulrike Hövelmann, Eric Zijlstra, Kirstine Stender-Petersen, Jacob Bonde Jacobsen, Hanne Haahr
Editorial comment by Professor Thomas Pieber
Improved pharmacokinetic and pharmacodynamic profiles of a new ultra-fast insulin analogue in an elderly population.
Management of diabetes mellitus in elderly subjects is complex, as this heterogeneous patient population includes individuals with diabetes who have additional chronic disorders, differing degrees of diabetes-related co-morbidities, cognitive impairment, and frailty. Treatment of elderly subjects with diabetes is further confounded by the limited clinical data currently available in this subject population regarding new insulin analogues. In this study, the pharmacokinetic and pharmacodynamic profiles of FIAsp, a new ultra-fast insulin analogue were investigated in elderly subjects. Faster insulin aspart is actually the molecule of insulin aspart prepared in a new formulation containing two well characterized excipients, niacinamide and L-arginine. The excipients, both approved by the FDA, result in a stable formulation and faster initial absorption after subcutaneous injection. In clinical trials in subjects with type 1 diabetes, FIAsp had a faster onset of appearance compared with insulin aspart (5 vs 11 min) and leads to a twofold higher insulin exposure in the first 30 minutes after single injection. In the current randomised, double-blind crossover trial 30 subjects with type 1 diabetes above 65 years have been compared against 37 younger type 1 diabetic subjects below 35 years of age. After injection of a single dose of either faster insulin aspart or insulin aspart (0.2 U/kg) pharmacokinetic and pharmacodynamic profile were assessed in a euglycaemic clamp. Onset of appearance was twice as fast, early insulin exposure, and early glucose lowering effects were greater for faster insulin aspart than for insulin aspart. The ultra-fast pharmacokinetic and pharmacodynamic properties of faster insulin aspart observed in younger adults are preserved in the elderly. These data suggest that faster aspart also has the potential to improve postprandial glucose control over current rapid-acting insulin analogues in elderly patients with diabetes.