A randomized, multicentre trial evaluating the efficacy and safety of fast‐acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5)

摘要

Aim To evaluate the efficacy and safety of fast‐acting insulin aspart (faster aspart) vs insulin aspart (IAsp) used in continuous subcutaneous insulin infusion (CSII) in participants with type 1 diabetes (T1D). Materials and Methods This was a double‐blind, treat‐to‐target, randomized, 16‐week trial investigating CSII treatment with faster aspart (n = 236) or IAsp (n = 236). All available information, regardless of treatment discontinuation, was used for the evaluation of effect. Results Faster aspart was non‐inferior to IAsp regarding the change from baseline in glycated haemoglobin (HbA1c; primary endpoint). The mean HbA1c changed from 58.4 mmol/mol (7.5%) at baseline to 57.8 mmol/mol (7.4%) with faster aspart and to 56.8 mmol/mol (7.4%) with IAsp after 16 weeks' treatment, with an estimated treatment difference (ETD) of 1.0 mmol/mol (95% confidence interval [CI] 0.14; 1.87) or 0.09% (95% CI 0.01; 0.17; P 0.001) for non‐inferiority (0.4% margin; P 0.02 for statistical significance in favour of IAsp). Faster aspart was superior to IAsp in change from baseline in 1‐hour postprandial glucose (PPG) increment after a meal test (ETD ?0.91 mmol/L [95% CI ?1.43; ?0.39] or ?16.4 mg/dL [95% CI ?25.7; ?7.0]; P = 0.001), with statistically significant reductions also at 30 minutes and 2 hours. The improvement in PPG was reflected in the change from baseline in 1‐hour interstitial glucose increment after all meals (ETD ?0.21 mmol/L [95% CI ?0.31; ?0.11] or ?3.77 mg/dL [95% CI ?5.53; ?2.01]). There was no statistically significant difference in the overall rate of severe or blood glucose‐confirmed hypoglycaemia (estimated rate ratio 1.00 [95% CI 0.85; 1.16]). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and 4‐week run‐in periods (4 vs 0). Conclusions Faster aspart provides an effective and safe option for CSII treatment in T1D.