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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.
Diabetes Obes Metab 2018; 20(5):1148-1155DO

Abstract

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.

Authors+Show Affiliations

Clinical and Experimental Endocrinology, University Hospital Leuven, Leuven, Belgium.Atlanta Diabetes Associates, Atlanta, Georgia.Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.Scripps Whittier Diabetes Institute, Scripps Health, San Diego, California.Institute of Diabetes Research, Münster, Germany.Biostatistics Aalborg 2, Novo Nordisk A/S, Aalborg, Denmark.Medical & Science, Insulin & Digital Health, Novo Nordisk A/S, Søborg, Denmark.Diabetes and Endocrinology, Royal Surrey County Hospital and University of Surrey, Guildford, UK.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29316130

Citation

Mathieu, Chantal, et al. "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." Diabetes, Obesity & Metabolism, vol. 20, no. 5, 2018, pp. 1148-1155.
Mathieu C, Bode BW, Franek E, et al. 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. Diabetes Obes Metab. 2018;20(5):1148-1155.
Mathieu, C., Bode, B. W., Franek, E., Philis-Tsimikas, A., Rose, L., Graungaard, T., ... Russell-Jones, D. (2018). 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. Diabetes, Obesity & Metabolism, 20(5), pp. 1148-1155. doi:10.1111/dom.13205.
Mathieu C, et al. 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. Diabetes Obes Metab. 2018;20(5):1148-1155. PubMed PMID: 29316130.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Mathieu,Chantal, AU - Bode,Bruce W, AU - Franek,Edward, AU - Philis-Tsimikas,Athena, AU - Rose,Ludger, AU - Graungaard,Tina, AU - Birk Østerskov,Anne, AU - Russell-Jones,David, Y1 - 2018/02/04/ PY - 2017/11/20/received PY - 2017/12/22/revised PY - 2017/12/28/accepted PY - 2018/1/10/pubmed PY - 2019/1/15/medline PY - 2018/1/10/entrez KW - insulin therapy KW - type 1 diabetes SP - 1148 EP - 1155 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 20 IS - 5 N2 - 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. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/29316130/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_ L2 - https://doi.org/10.1111/dom.13205 DB - PRIME DP - Unbound Medicine ER -