This column highlights recent clinical trial data and landmark trials to provide relevant information and links for obtaining trial data and articles to facilitate discussion with patients and other providers. The trial is identified by its acronym, its ClinicalTrials.gov Identifier (NCT Number) and its journal reference.
A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-acting Insulin Aspart in Adults with Type 1 Diabetes
Authors: Heise T, Pieber TR, Danne T, Erichsen L, Haahr H.
ClinicalTrials.gov Identifier: NCT02035371, NCT01924637, NCT02131246, NCT02033239, NCT02003677, NCT01618188.
References (related):1. Buckley ST, Kildegaard J, Høiberg-Nielsen R, et al. Mechanistic analysis into the mode of action of niacinamide in faster-acting insulin aspart. Diabetes Technol Ther. 2016;18(Suppl 1):A116–7. 2. Fath M, Danne T, Biester T, et al. Faster-acting insulin aspart provides faster onset and greater early exposure versus insulin aspart in children and adolescents with Type 1 diabetes mellitus. Pediatr Diabetes. 2017. doi:10.1111/pedi.12506. 3. Heise T, Stender-Petersen K, Hövelmann U, et al. Pharmacokinetic and pharmacodynamic properties of faster-acting insulin aspart versus insulin aspart across a clinically relevant dose range in subjects with Type 1 diabetes mellitus. Clinical Pharmacokinet. 2016. doi:10.1007/s40262-016-0473-5. 4. Heise T, Hövelmann U, Zijlstra E, et al. A comparison of pharmacokinetic and pharmacodynamic properties between faster-acting insulin aspart and insulin aspart in elderly subjects with Type 1 diabetes mellitus. Drugs Aging. 2017;34(1):29–38. 5. Heise T, Hövelmann U, Brøndsted L, et al. Faster-acting insulin aspart: earlier onset of appearance and greater early pharmacokinetic and pharmacodynamic effects than insulin aspart. Diabetes Obes Metab. 2015;17:682–8. 6. Russell-Jones D, Bode B, De Block C, et al. Double-blind mealtime faster-acting insulin aspart versus insulin aspart in basal-bolus improves glycemic control in T1D: the onset® 1 trial. Can J Diabetes. 2016;40(5 Suppl.):S58. 7. Bowering K, Case C, Harvey J, et al. Faster-acting insulin aspart versus insulin aspart as part of basal-bolus therapy improves postprandial glycemic control in uncontrolled T2D in the double-blinded onset® 2 trial. Can J Diabetes. 2016;40(5 Suppl.):S57.
Sponsor: Novo Nordisk A/S
Study Design: Pooled analysis of 218 adult subjects with Type 1 diabetes from six randomized, double-blind, crossover trials in the faster insulin aspart (FIAsp) clinical development program.
Primary Outcome Measure: Comparison of the pharmacokinetic and pharmacodynamic profiles of fast-acting insulin aspart (faster aspart; FIAsp) with insulin aspart (IAsp).
Results: Onset of appearance of faster aspart occurred 4.9 minutes earlier than insulin aspart. The early glucose-lowering effect (AUCGIR,0–30 minutes) was 74 percent greater and offset of glucose-lowering effect occurred 14.3 minutes earlier for faster aspart versus IAsp. Total exposure and total glucose-lowering effect did not differ significantly between treatments.
Summary: Faster aspart is a step forward in the goal of mimicking the physiologic prandial insulin secretion. It is important to note that this new formulation of insulin aspart provides a faster onset of appearance of insulin into the system but still takes about 30 minutes to come to full effect. With this faster onset and faster off, if taken at least 5 minutes prior to onset of a meal, it has the potential to improve postprandial glucose control compared with the currently available insulin aspart (IAsp).
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About our expert: Kathleen Wyne, MD, PhD, FACE, FNLA, Associate Professor, Division of Endocrinology, Diabetes and Metabolism, The Ohio State University, Wexner Medical Center, Columbus