1. Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension
- Author
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Juliana M. Bue-Valleskey, Leslie J. Klaff, Nanette C. Schloot, Janet Tobian, Mary Anne Dellva, Jang Ik Cho, Dominik Dahl, and Junnosuke Miura
- Subjects
Insulin degludec ,medicine.medical_specialty ,endocrine system diseases ,Lispro ,Endocrinology, Diabetes and Metabolism ,030209 endocrinology & metabolism ,030204 cardiovascular system & hematology ,Ultra rapid lispro ,03 medical and health sciences ,0302 clinical medicine ,Diabetes mellitus ,Internal medicine ,Internal Medicine ,Clinical endpoint ,Type 1 diabetes ,Medicine ,Original Research ,Glycemic ,business.industry ,digestive, oral, and skin physiology ,nutritional and metabolic diseases ,medicine.disease ,Confidence interval ,Postprandial ,business ,Postprandial Hypoglycemia - Abstract
Introduction The PRONTO-T1D study, which evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes (T1D), met the primary endpoint of noninferiority of HbA1c change from baseline compared to lispro at 26 weeks. We present results of an additional 26-week treatment phase evaluating long-term efficacy and safety of URLi. Methods In this phase 3, treat-to-target study, subjects were randomized to double-blind mealtime URLi, lispro, or open-label postmeal URLi with insulin degludec or glargine for 26 weeks. Subjects in the double-blind URLi (n = 451) and lispro (n = 442) groups continued for another 26 weeks to assess long-term efficacy and safety. Results HbA1c increased marginally during the long-term maintenance period (week 26–52) in both groups to 7.47% (URLi) and 7.54% (lispro). At week 52, there were no statistically significant treatment differences in change from baseline HbA1c with a least-squares mean treatment difference (95% confidence interval) of − 0.06% (− 0.16, 0.03). Proportions of patients with HbA1c
- Published
- 2021