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

Abstract

AimTo 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).MethodsThis multicentre, treat‐to‐target trial (Clinical trial registry: NCT02500706, http://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.ResultsNon‐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.ConclusionMealtime 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.

Mealtime fast‐acting insulin aspart versus insulin aspart for controlling postprandial hyperglycaemia in people with insulin‐resistant Type 2 diabetes

“…In people with Type 1 diabetes, mealtime faster aspart was shown to be non-inferior to mealtime insulin aspart in reducing HbA 1c [7,8]. In people with Type 1 diabetes, mealtime faster aspart was shown to be non-inferior to mealtime insulin aspart in reducing HbA 1c [7,8].…”

“…Further, faster aspart demonstrated superior PPG control with statistically significant improvements in both 1-h PPG [7,8] and 2-h PPG increments [7], compared with mealtime insulin aspart in people with Type 1 diabetes. In both Type 1 and Type 2 diabetes, the overall rates of treatment-emergent hypoglycaemia and safety profiles were similar between the mealtime faster aspart and insulin aspart treatment arms [7][8][9]. In both Type 1 and Type 2 diabetes, the overall rates of treatment-emergent hypoglycaemia and safety profiles were similar between the mealtime faster aspart and insulin aspart treatment arms [7][8][9].…”

“…Fast-acting insulin aspart (faster aspart) is a novel formulation of insulin aspart containing niacinamide and Larginine, with an absorption profile that more closely approaches physiological early-phase insulin secretion than conventional rapid-acting insulin analogues. In people with Type 1 diabetes, mealtime faster aspart was shown to be non-inferior to mealtime insulin aspart in reducing HbA 1c [7,8]. Further, faster aspart demonstrated superior PPG control with statistically significant improvements in both 1-h PPG [7,8] and 2-h PPG increments [7], compared with mealtime insulin aspart in people with Type 1 diabetes.…”

“…In people with Type 1 diabetes, mealtime faster aspart was shown to be non-inferior to mealtime insulin aspart in reducing HbA 1c [7,8]. Further, faster aspart demonstrated superior PPG control with statistically significant improvements in both 1-h PPG [7,8] and 2-h PPG increments [7], compared with mealtime insulin aspart in people with Type 1 diabetes. In Type 2 diabetes, mealtime faster aspart was also demonstrated to be non-inferior to mealtime insulin aspart in terms of HbA 1c , with a statistically significant improvement in 1-h PPG increment in favour of faster aspart [9].…”

“…In Type 2 diabetes, mealtime faster aspart was also demonstrated to be non-inferior to mealtime insulin aspart in terms of HbA 1c , with a statistically significant improvement in 1-h PPG increment in favour of faster aspart [9]. In both Type 1 and Type 2 diabetes, the overall rates of treatment-emergent hypoglycaemia and safety profiles were similar between the mealtime faster aspart and insulin aspart treatment arms [7][8][9].…”