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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).

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.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30537180

Citation

Klonoff, David C., et al. "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)." Diabetes, Obesity & Metabolism, 2018.
Klonoff DC, Evans ML, Lane W, et al. 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). Diabetes Obes Metab. 2018.
Klonoff, D. C., Evans, M. L., Lane, W., Kempe, H. P., Renard, E., DeVries, J. H., ... Battelino, T. (2018). 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). Diabetes, Obesity & Metabolism, doi:10.1111/dom.13610.
Klonoff DC, et al. 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). Diabetes Obes Metab. 2018 Dec 9; PubMed PMID: 30537180.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Klonoff,David C, AU - Evans,Mark L, AU - Lane,Wendy, AU - Kempe,Hans-Peter, AU - Renard,Eric, AU - DeVries,J Hans, AU - Graungaard,Tina, AU - Hyseni,Agon, AU - Gondolf,Theis, AU - Battelino,Tadej, Y1 - 2018/12/09/ PY - 2018/09/04/received PY - 2018/12/05/revised PY - 2018/12/05/accepted PY - 2018/12/12/pubmed PY - 2018/12/12/medline PY - 2018/12/12/entrez KW - CSII KW - clinical trial KW - insulin therapy KW - type 1 diabetes JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab N2 - 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. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/30537180/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__ L2 - https://doi.org/10.1111/dom.13610 DB - PRIME DP - Unbound Medicine ER -