Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart
| Autor: | Ann Kathrine Hansen, Masanari Shiramoto, Hanne Haahr, Tomoyuki Nishida |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty endocrine system diseases Endocrinology Diabetes and Metabolism Urology 030209 endocrinology & metabolism Insulin aspart Young Adult 03 medical and health sciences 0302 clinical medicine Asian People Double-Blind Method Japan Diabetes mellitus Internal medicine Internal Medicine medicine Humans Hypoglycemic Agents Pharmacokinetics 030212 general & internal medicine Insulin Aspart Type 1 diabetes Cross-Over Studies business.industry nutritional and metabolic diseases Articles General Medicine Middle Aged medicine.disease Clinical Trial Crossover study Confidence interval Clinical Science and Care Diabetes Mellitus Type 1 Treatment Outcome Endocrinology Pharmacodynamics Japanese Female Onset of action business medicine.drug Blood sampling |
| Zdroj: | Journal of Diabetes Investigation |
| ISSN: | 2040-1116 |
| DOI: | 10.1111/jdi.12697 |
| Popis: | Introduction Fast‐acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with two added excipients (niacinamide and L‐arginine) in order to obtain accelerated absorption after subcutaneous dosing. The present study compared the pharmacokinetic/pharmacodynamic characteristics of faster aspart vs IAsp in Japanese patients with type 1 diabetes. Materials and Methods In a randomized, double‐blind, cross‐over design, 43 participants were given faster aspart and IAsp (0.2 U/kg single dose) at two separate dosing visits. Frequent pharmacokinetic blood sampling was carried out, and pharmacodynamics were assessed using an automated euglycemic clamp lasting for a maximum of 12 h after dosing (target 5.5 mmol/L). Results Faster aspart showed onset of appearance approximately twice‐as‐fast vs IAsp (least squares means: 3.0 vs 7.1 min; estimated treatment difference −4.1 min, 95% confidence interval [CI]: −5.0, −3.2; P < 0.001) and onset of action occurring approximately 5 min earlier (20.2 vs 25.5 min; estimated treatment difference −5.3 min, 95% CI: −8.4, −2.2; P = 0.001). Within the first 30 min post‐dose, both exposure (area under the curve [AUC]IA sp,0–30 min) and glucose‐lowering effect (AUCGIR ,0–30 min) were approximately twofold greater for faster aspart vs IAsp (P < 0.001 and P = 0.002, respectively). Bioavailability of faster aspart was similar to IAsp (AUCIA sp,0‐t; estimated treatment ratio 0.99, 90% CI: 0.96–1.02), whereas the total glucose‐lowering effect (AUCGIR ,0–t) was slightly lower for faster aspart vs IAsp (estimated treatment ratio 0.93, 95% CI: 0.87–0.99, P = 0.020). Conclusions Faster aspart showed faster onset, higher early exposure and a greater early glucose‐lowering effect relative to IAsp in Japanese patients with type 1 diabetes, in accordance with previous findings in Caucasian type 1 diabetes patients. |
| Databáze: | OpenAIRE |
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