Premium
Efficacy and safety of fast‐acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52‐week, randomized, treat‐to‐target, phase III trial
Author(s) -
Mathieu Chantal,
Bode Bruce W.,
Franek Edward,
PhilisTsimikas Athena,
Rose Ludger,
Graungaard Tina,
Birk Østerskov Anne,
RussellJones David
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.13205
Subject(s) - insulin aspart , medicine , postprandial , insulin detemir , clinical endpoint , randomized controlled trial , type 2 diabetes , type 1 diabetes , adverse effect , insulin , diabetes mellitus , endocrinology , insulin glargine
Aims To compare the safety and efficacy of fast‐acting insulin aspart (faster aspart) with conventional insulin aspart (IAsp) in adults with type 1 diabetes (T1D). Materials and methods onset 1 was a randomized, multicentre, treat‐to‐target, phase III, 52‐week (initial 26 weeks + additional 26 weeks) trial conducted at 165 sites across 9 countries. Adults with T1D were randomly allocated to double‐blind mealtime faster aspart or IAsp, each with once‐ or twice‐daily insulin detemir. The primary endpoint, change in glycated haemoglobin (HbA1c) from baseline after the initial 26 weeks, has been reported previously. In the present paper, we report data from the full 52‐week study period. Results Between August 2013 and June 2015, 381 participants were assigned to double‐blind faster aspart and 380 participants to IAsp. After 52 weeks, estimated mean changes from baseline in HbA1c levels were −0.08% (faster aspart) and +0.01% (IAsp); estimated treatment difference significantly favoured faster aspart (−0.10% [95% confidence interval {CI} −0.19;−0.00]; P = .0424). Changes from baseline in 1‐hour postprandial plasma glucose (PPG) increment (meal test; faster aspart −1.05 mmol/L; IAsp −0.14 mmol/L) also significantly favoured faster aspart (estimated treatment difference −0.91 mmol/L [95% CI −1.40;−0.43]; −16.48 mg/dL [95% CI −25.17;−7.80]; P = .0002). There was no difference in overall severe or blood glucose‐confirmed hypoglycaemic episodes or treatment‐emergent adverse events between treatments. Conclusions At 52 weeks, overall glycaemic control had significantly improved with faster aspart vs IAsp, consistent with the 26‐week study findings. Achieving an insulin profile closer to physiological insulin secretion with faster aspart translates into lower PPG and HbA1c levels compared with those achieved with IAsp in people with T1D.