Format

Send to

Choose Destination
Diabetes Obes Metab. 2018 Dec 9. doi: 10.1111/dom.13610. [Epub ahead of print]

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).

Author information

1
Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, California.
2
Wellcome Trust/MRC Institute of Metabolic Science and Department of Medicine, University of Cambridge, Cambridge, UK.
3
Mountain Diabetes and Endocrine Center, Asheville, North Carolina.
4
Centre for Diabetes and Nutrition Ludwigshafen, Ludwigshafen, Germany.
5
Department of Endocrinology, Diabetes, and Nutrition and Clinical Investigation Centre, Montpellier University Hospital, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France.
6
Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
7
Profil Institute of Metabolic Research, Neuss, Germany.
8
Novo Nordisk A/S, Aalborg, Denmark.
9
Novo Nordisk A/S, Søborg, Denmark.
10
Department of Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.

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.

KEYWORDS:

CSII; clinical trial; insulin therapy; type 1 diabetes

PMID:
30537180
DOI:
10.1111/dom.13610

Supplemental Content

Full text links

Icon for Wiley
Loading ...
Support Center