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Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial.
Diabetes Care 2019; 42(7):1255-1262DC

Abstract

OBJECTIVE

To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes.

RESEARCH DESIGN AND METHODS

After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart (n = 260), mealtime IAsp (n = 258), or open-label postmeal faster aspart (n = 259). The primary end point was change from baseline in glycated hemoglobin (HbA1c) after 26 weeks of treatment. All available information regardless of treatment discontinuation was used for the evaluation of treatment effect.

RESULTS

At week 26, mealtime and postmeal faster aspart were noninferior to IAsp regarding change from baseline in HbA1c (P < 0.001 for noninferiority [0.4% margin]), with a statistically significant difference in favor of mealtime faster aspart (estimated treatment difference -0.17% [95% CI -0.30; -0.03], -1.82 mmol/mol [-3.28; -0.36]; P = 0.014). Change from baseline in 1-h postprandial glucose increment significantly favored mealtime faster aspart versus IAsp at breakfast, main evening meal, and over all meals (P < 0.01 for all). No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed. Mean total daily insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp.

CONCLUSIONS

In children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA1c control compared with IAsp.

Authors+Show Affiliations

Atlanta Diabetes Associates, Atlanta, GA bbode001@gmail.com.University Hospital St. Marina, Medical University Varna, Varna, Bulgaria.Pediatric Department, Novosibirsk State Medical University of the Ministry of Health of the Russian Federation, Novosibirsk, Russia.Joslin Diabetes Center, Harvard Medical School, Boston, MA.Diabetes Research Society, Hyderabad, India.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Children's Hospital Auf der Bult, Hannover, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31076415

Citation

Bode, Bruce W., et al. "Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: the Onset 7 Trial." Diabetes Care, vol. 42, no. 7, 2019, pp. 1255-1262.
Bode BW, Iotova V, Kovarenko M, et al. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. Diabetes Care. 2019;42(7):1255-1262.
Bode, B. W., Iotova, V., Kovarenko, M., Laffel, L. M., Rao, P. V., Deenadayalan, S., ... Danne, T. (2019). Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. Diabetes Care, 42(7), pp. 1255-1262. doi:10.2337/dc19-0009.
Bode BW, et al. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: the Onset 7 Trial. Diabetes Care. 2019;42(7):1255-1262. PubMed PMID: 31076415.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. AU - Bode,Bruce W, AU - Iotova,Violeta, AU - Kovarenko,Margarita, AU - Laffel,Lori M, AU - Rao,Paturi V, AU - Deenadayalan,Srikanth, AU - Ekelund,Magnus, AU - Larsen,Steffen Falgreen, AU - Danne,Thomas, Y1 - 2019/05/10/ PY - 2019/01/02/received PY - 2019/04/09/accepted PY - 2019/5/12/pubmed PY - 2019/5/12/medline PY - 2019/5/12/entrez SP - 1255 EP - 1262 JF - Diabetes care JO - Diabetes Care VL - 42 IS - 7 N2 - OBJECTIVE: To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes. RESEARCH DESIGN AND METHODS: After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart (n = 260), mealtime IAsp (n = 258), or open-label postmeal faster aspart (n = 259). The primary end point was change from baseline in glycated hemoglobin (HbA1c) after 26 weeks of treatment. All available information regardless of treatment discontinuation was used for the evaluation of treatment effect. RESULTS: At week 26, mealtime and postmeal faster aspart were noninferior to IAsp regarding change from baseline in HbA1c (P < 0.001 for noninferiority [0.4% margin]), with a statistically significant difference in favor of mealtime faster aspart (estimated treatment difference -0.17% [95% CI -0.30; -0.03], -1.82 mmol/mol [-3.28; -0.36]; P = 0.014). Change from baseline in 1-h postprandial glucose increment significantly favored mealtime faster aspart versus IAsp at breakfast, main evening meal, and over all meals (P < 0.01 for all). No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed. Mean total daily insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp. CONCLUSIONS: In children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA1c control compared with IAsp. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/31076415/Efficacy_and_Safety_of_Fast_Acting_Insulin_Aspart_Compared_With_Insulin_Aspart_Both_in_Combination_With_Insulin_Degludec_in_Children_and_Adolescents_With_Type_1_Diabetes:_The_onset_7_Trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=31076415 DB - PRIME DP - Unbound Medicine ER -