A single‐dose euglycaemic clamp study in two cohorts to compare the exposure of SAR341402 (insulin aspart) Mix 70/30 with US ‐ and European‐ approved versions of insulin aspart Mix 70/30 and SAR341402 rapid‐acting solution in subjects with type 1 diabetes
| العنوان: | A single‐dose euglycaemic clamp study in two cohorts to compare the exposure of |
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| المؤلفون: | Wolfgang Schmider, Bhaswati Mukherjee, Christoph Kapitza, Lenore Teichert, Irene Nowotny, Leszek Nosek |
| المصدر: | Diabetes, Obesity and Metabolism. 23:674-681 |
| بيانات النشر: | Wiley, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, Type 1 diabetes, business.industry, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, medicine.disease, Crossover study, Confidence interval, Insulin aspart, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Pharmacokinetics, Internal medicine, Pharmacodynamics, Cohort, Internal Medicine, medicine, Dosing, business, medicine.drug |
| الوصف: | AIM To compare the pharmacokinetic exposure of SAR341402 Mix 70/30 (SARAsp -Mix) with US- and European (EU)-approved versions of insulin aspart Mix 70/30 (NovoLog Mix 70/30 [NN-Mix-US]/NovoMix 30 [NN-Mix-EU]) and SAR341402 insulin aspart solution (SAR-Asp) in subjects with type 1 diabetes. MATERIALS AND METHODS This was a randomized, double-blind, crossover trial in two cohorts. Fifty-two subjects received a single subcutaneous 0.3 U/kg dose of each treatment and underwent a euglycaemic clamp procedure lasting for a maximum of 24 hours after dosing. In cohort 1, subjects (N = 36) were exposed once each to SARAsp -Mix, NN-Mix-US and NN-Mix-EU. In cohort 2, subjects (N = 16) were exposed once each to SARAsp -Mix and SAR-Asp. RESULTS Of the 52 subjects randomized, 48 completed all treatment periods. In cohort 1, the extent of exposure (total and maximum concentration) was similar among the three treatments, with the 90% confidence intervals for pairwise treatment ratios meeting the predefined acceptance range (0.80 to 1.25). In cohort 2, statistically significant differences (P |
| تدمد: | 1463-1326 1462-8902 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_________::78bdaafa2c988eb1e480252ceaa93718Test https://doi.org/10.1111/dom.14260Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi...........78bdaafa2c988eb1e480252ceaa93718 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14631326 14628902 |
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