The Efficacy and Safety of Insulin Degludec Given in Variable Once-Daily Dosing Intervals Compared With Insulin Glargine and Insulin Degludec Dosed at the Same Time Daily

• DOI: 10.2337/dc12-1668
• Publication Date: 2013-01-23T02:37:02Z
• Authors: Luigi Meneghini; Stephen L. Atkin; Stephen C.L. Gough; Itamar Raz; Lawrence Blonde; Marina Shestakova; Stephen Bain; Thue Johansen; Kamilla Begtrup; Kåre I. Birkeland
• Keywords: Insulin degludec

The requirement to inject current basal insulin analogs at a fixed time each day may complicate adherence and compromise glycemic control. This trial evaluated the efficacy safety of varying daily injection degludec (IDeg), an ultra-long-acting insulin.This 26-week, open-label, treat-to-target enrolled adults (≥18 years) with type 2 diabetes who were either naïve receiving oral antidiabetic drugs (OADs) (HbA(1c) = 7-11%) or previously on ± OAD(s) 7-10%). Participants randomized 1) once-daily (OD) IDeg in prespecified dosing schedule, creating 8-40-h intervals between injections (IDeg OD Flex; n 229); 2) main evening meal OD; 228); 3) glargine same (IGlar 230). primary outcome was noninferiority Flex IGlar HbA(1c) reduction after 26 weeks.After weeks, Flex, OD, improved by 1.28, 1.07, 1.26% points, respectively (estimated treatment difference [IDeg - OD]: 0.04% points [-0.12 0.20], confirming noninferiority). No statistically significant differences overall nocturnal hypoglycemia found OD. Comparable control rates seen Adverse event profiles similar across groups.The use extreme 8-40 h demonstrates that can be varied without compromising safety.