Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week PRONTO‐T1D study
| العنوان: | Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26‐week |
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| المؤلفون: | Juliana M. Bue-Valleskey, Dachuang Cao, Dominik Dahl, Junnosuke Miura, Janet Tobian, Jean Lucas, Mary Anne Dellva, Leslie J. Klaff |
| المصدر: | Diabetes, Obesity & Metabolism |
| بيانات النشر: | Wiley, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Blood Glucose, medicine.medical_specialty, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Insulin Glargine, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Gastroenterology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Clinical endpoint, Humans, Hypoglycemic Agents, Insulin lispro, Glycated Hemoglobin, Type 1 diabetes, Insulin Lispro, business.industry, Insulin glargine, digestive, oral, and skin physiology, Original Articles, Postprandial Period, medicine.disease, Confidence interval, Diabetes Mellitus, Type 1, Postprandial, Original Article, business, medicine.drug |
| الوصف: | Aims To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26‐week, treat‐to‐target, phase 3 trial. Materials and methods After an 8‐week lead‐in to optimize basal insulin glargine or degludec, patients were randomized to double‐blind mealtime URLi (n = 451) or lispro (n = 442), or open‐label post‐meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non‐inferiority margin 0.4%), with multiplicity‐adjusted objectives for postprandial glucose (PPG) excursions after a meal test. Results Both mealtime and post‐meal URLi demonstrated non‐inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi −0.08% [95% confidence interval (CI) −0.16, 0.00] and for post‐meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post‐meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1‐ and 2‐hour PPG excursions during the meal test: ETD −1.55 mmol/L (95% CI −1.96, −1.14) at 1 hour and − 1.73 mmol/L (95% CI −2.28, −1.18) at 2 hours (both P 4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post‐meal URLi, and 0.2% on lispro. Overall, the incidence of treatment‐emergent adverse events was similar between treatments. Conclusions The results showed that URLi provided good glycaemic control, with non‐inferiority to lispro confirmed for both mealtime and post‐meal URLi, while superior PPG control was demonstrated with mealtime dosing. |
| تدمد: | 1463-1326 1462-8902 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6919b0f1fc37568dad2ba3fbd7e81aacTest https://doi.org/10.1111/dom.14100Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....6919b0f1fc37568dad2ba3fbd7e81aac |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14631326 14628902 |
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