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). Issue 4 (13th January 2019)

• Record Type: Journal Article
• Authors: Klonoff, David C.; Evans, Mark L.; Lane, Wendy; Kempe, Hans‐Peter; Renard, Eric; DeVries, J. Hans; Graungaard, Tina; Hyseni, Agon; Gondolf, Theis; Battelino, Tadej
• Is Part Of: Diabetes, obesity & metabolism. Volume 21:Issue 4(2019)
• Page Start: 961
• Page End: 967
• Publication Date: 2019-01-13
• Subjects: clinical trial -- CSII -- insulin therapy -- type 1 diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.13610
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract : 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.