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A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (Onset 9).
Diabetes Care. 2020 Mar 24 [Online ahead of print]DC

Abstract

OBJECTIVE

To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without metformin, in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.

RESEARCH DESIGN AND METHODS

This multicenter, double-blind, treat-to-target trial randomized participants to faster aspart (n = 546) or IAsp (n = 545). All available information, regardless of treatment discontinuation or use of ancillary treatment, was used for evaluation of effect.

RESULTS

Noninferiority for the change from baseline in HbA1c 16 weeks after randomization (primary end point) was confirmed for faster aspart versus IAsp (estimated treatment difference [ETD] -0.04% [95% CI -0.11; 0.03]; -0.39 mmol/mol [-1.15; 0.37]; P < 0.001). Faster aspart was superior to IAsp for change from baseline in 1-h postprandial glucose (PPG) increment using a meal test (ETD -0.40 mmol/L [-0.66; -0.14]; -7.23 mg/dL [-11.92; -2.55]; P = 0.001 for superiority). Change from baseline in self-measured 1-h PPG increment for the mean over all meals favored faster aspart (ETD -0.25 mmol/L [-0.42; -0.09]); -4.58 mg/dL [-7.59; -1.57]; P = 0.003). The overall rate of treatment-emergent severe or blood glucose (BG)-confirmed hypoglycemia was statistically significantly lower for faster aspart versus IAsp (estimated treatment ratio 0.81 [95% CI 0.68; 0.97]).

CONCLUSIONS

In combination with insulin degludec, faster aspart provided effective overall glycemic control, superior PPG control, and a lower rate of severe or BG-confirmed hypoglycemia versus IAsp in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.

Authors+Show Affiliations

Mountain Diabetes and Endocrine Centre, Asheville, NC mountaindiabetes@msn.com.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.Novo Nordisk A/S, Aalborg, Denmark.Santojanni Hospital and CENUDIAB, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina.Institute of Diabetes Research, Münster, Germany.Division of Endocrinology and Metabolism, University of Alberta, Edmonton, AB, Canada.Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.Service of Endocrinology and Nutrition, University Hospital of A Coruña, La Coruña, Spain.Mossakowski Clinical Research Center, Polish Academy of Sciences, and Department of Endocrinology and Diabetology, CSK MSWiA, Warsaw, Poland.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32209647

Citation

Lane, Wendy S., et al. "A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (Onset 9)." Diabetes Care, 2020.
Lane WS, Favaro E, Rathor N, et al. A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (Onset 9). Diabetes Care. 2020.
Lane, W. S., Favaro, E., Rathor, N., Jang, H. C., Kjærsgaard, M. I. S., Oviedo, A., Rose, L., Senior, P., Sesti, G., Soto Gonzalez, A., & Franek, E. (2020). A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (Onset 9). Diabetes Care. https://doi.org/10.2337/dc19-2232
Lane WS, et al. A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (Onset 9). Diabetes Care. 2020 Mar 24; PubMed PMID: 32209647.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (Onset 9). AU - Lane,Wendy S, AU - Favaro,Elena, AU - Rathor,Naveen, AU - Jang,Hak C, AU - Kjærsgaard,Maiken I S, AU - Oviedo,Alejandra, AU - Rose,Ludger, AU - Senior,Peter, AU - Sesti,Giorgio, AU - Soto Gonzalez,Alfonso, AU - Franek,Edward, Y1 - 2020/03/24/ PY - 2019/11/06/received PY - 2020/02/15/accepted PY - 2020/3/27/entrez PY - 2020/3/27/pubmed PY - 2020/3/27/medline JF - Diabetes care JO - Diabetes Care N2 - OBJECTIVE: To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without metformin, in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen. RESEARCH DESIGN AND METHODS: This multicenter, double-blind, treat-to-target trial randomized participants to faster aspart (n = 546) or IAsp (n = 545). All available information, regardless of treatment discontinuation or use of ancillary treatment, was used for evaluation of effect. RESULTS: Noninferiority for the change from baseline in HbA1c 16 weeks after randomization (primary end point) was confirmed for faster aspart versus IAsp (estimated treatment difference [ETD] -0.04% [95% CI -0.11; 0.03]; -0.39 mmol/mol [-1.15; 0.37]; P < 0.001). Faster aspart was superior to IAsp for change from baseline in 1-h postprandial glucose (PPG) increment using a meal test (ETD -0.40 mmol/L [-0.66; -0.14]; -7.23 mg/dL [-11.92; -2.55]; P = 0.001 for superiority). Change from baseline in self-measured 1-h PPG increment for the mean over all meals favored faster aspart (ETD -0.25 mmol/L [-0.42; -0.09]); -4.58 mg/dL [-7.59; -1.57]; P = 0.003). The overall rate of treatment-emergent severe or blood glucose (BG)-confirmed hypoglycemia was statistically significantly lower for faster aspart versus IAsp (estimated treatment ratio 0.81 [95% CI 0.68; 0.97]). CONCLUSIONS: In combination with insulin degludec, faster aspart provided effective overall glycemic control, superior PPG control, and a lower rate of severe or BG-confirmed hypoglycemia versus IAsp in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/32209647/A_Randomized_Trial_Evaluating_the_Efficacy_and_Safety_of_Fast_Acting_Insulin_Aspart_Compared_With_Insulin_Aspart_Both_in_Combination_With_Insulin_Degludec_With_or_Without_Metformin_in_Adults_With_Type_2_Diabetes__Onset_9__ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=32209647 DB - PRIME DP - Unbound Medicine ER -
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