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Fast‐acting insulin aspart versus insulin aspart in the setting of insulin degludec‐treated type 1 diabetes: Efficacy and safety from a randomized double‐blind trial
Author(s) -
Buse John B.,
Carlson Anders L.,
Komatsu Mitsuhisa,
Mosenzon Ofri,
Rose Ludger,
Liang Bo,
Buchholtz Kristine,
Horio Hiroshi,
Kadowaki Takashi
Publication year - 2018
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13545
Subject(s) - insulin aspart , medicine , type 2 diabetes , discontinuation , clinical endpoint , insulin degludec , insulin , randomization , randomized controlled trial , diabetes mellitus , endocrinology , postprandial , basal insulin
Aim To evaluate the efficacy and safety of mealtime or post‐meal fast‐acting insulin aspart (faster aspart) vs mealtime insulin aspart (IAsp), both in combination with insulin degludec, in participants with type 1 diabetes (T1D). Methods This multicentre, treat‐to‐target trial (Clinical trial registry: NCT02500706, ClinicalTrials.gov ) randomized participants to double‐blind mealtime faster aspart ( n = 342) or IAsp ( n = 342) or open‐label post‐meal faster aspart ( n = 341). The primary endpoint was change from baseline in HbA1c 26 weeks post randomization. All available information, regardless of treatment discontinuation, was used for evaluation of the effect. Results Non‐inferiority for the change from baseline in HbA1c was confirmed for mealtime and post‐meal faster aspart vs IAsp (estimated treatment difference [ETD]: 95%CI, −0.02% [−0.11; 0.07] and 0.10% [0.004; 0.19], respectively). Mealtime faster aspart was superior to IAsp for 1‐hour PPG increment using a meal test (ETD, −0.90 mmol/L [−1.36; –0.45]; P < 0.001). Self‐monitored 1‐hour PPG increment favoured faster aspart at breakfast (ETD, −0.58 mmol/L [−0.99; −0.17]; P = 0.006) and across all meals (−0.48 mmol/L [−0.74; −0.21]; P < 0.001). Safety profiles and overall rate of severe or blood glucose‐confirmed hypoglycaemia were similar between treatments, but significantly less hypoglycaemia was seen 3 to 4 hours after meals with mealtime faster aspart. Conclusion Mealtime and post‐meal faster aspart in conjunction with insulin degludec provided effective glycaemic control compared with IAsp, with no increased safety risk. Mealtime faster aspart provided PPG control superior to that of IAsp.