Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial

被引:12
作者
Battelino, Tadej [1 ,2 ]
Deeb, Larry C. [3 ]
Ekelund, Magnus [4 ]
Kinduryte, Ona [5 ,11 ]
Klingensmith, Georgeanna J. [6 ,7 ]
Kocova, Mirjana [8 ]
Kovarenko, Margarita [9 ]
Shehadeh, Naim [10 ]
机构
[1] UMC Univ Childrens Hosp, Dept Endocrinol Diabet & Metab, Bohoriceva 20, Ljubljana 1000, Slovenia
[2] Univ Ljubljana, Fac Med, Ljubljana, Slovenia
[3] Florida State Univ, Coll Med, Tallahassee, FL 32306 USA
[4] Novo Nordisk AS, Soborg, Denmark
[5] Novo Nordisk AS, Bagsvaerd, Denmark
[6] Univ Colorado, Barbara Davis Ctr Childhood Diabet, Aurora, CO USA
[7] Childrens Hosp Colorado, Aurora, CO USA
[8] Univ Pediat Clin Skopje, Dept Endocrinol & Genet, Skopje, Macedonia
[9] Novosibirsk State Med Univ, Pediat Dept, Minist Healthcare Russian Federat, Novosibirsk, Russia
[10] Technion, Bruce Rappaport Fac Med, Rambam Hlth Care Campus, Haifa, Israel
[11] Boehringer Ingelheim GmbH & Co KG, Binger Str 173, D-55216 Ingelheim, Germany
关键词
adolescent; child; insulin degludec/insulin aspart; insulin detemir; type; 1; diabetes; GLYCEMIC CONTROL; YOUNG-CHILDREN; NPH INSULIN; GLARGINE; GLUCOSE; DETEMIR; HYPOGLYCEMIA; THERAPY; ANALOGS; GROWTH;
D O I
10.1111/pedi.12724
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co-formulation of basal and bolus insulin. Objective To evaluate efficacy and safety of IDegAsp in pediatric patients with type 1 diabetes (T1D). Subjects Children and adolescents (aged 1 to <18 years) with T1D. Methods A 16-week, phase 3b, treat-to-target, parallel-group, open-label, non-inferiority trial was conducted at 63 sites in 14 countries from October 2013 to November 2014. Patients were randomized 1:1 (age stratified: 1-<6years; 6-<12 years; 12-<18 years) to IDegAsp once daily (OD) plus insulin aspart (IAsp) for remaining meals (IDegAsp+IAsp), or IDet OD or twice daily plus mealtime IAsp (IDet+IAsp). The primary end-point was HbA1c change from baseline at week 16. Results A total of 362 participants were randomized to IDegAsp+IAsp (n=182) or IDet+ IAsp (n=180). HbA1c decreased from baseline to week 16 by 0.3% in both groups (estimated treatment difference: -0.04%-points [-0.23; 0.15](95%CI) (-0.45mmol/mol [-2.51; 1.60](95%CI)), confirming non-inferiority. There were no significant differences between treatment groups in fasting or self-measured plasma glucose. Confirmed hypoglycemia rates did not significantly differ between groups. There was a significant reduction in basal and total insulin dose with IDegAsp+IAsp vs IDet+IAsp (post hoc analysis). Mean number of injections/day was 3.6 and 4.9 with IDegAsp+IAsp and IDet+IAsp, respectively (post hoc analysis). A non-significant higher rate of severe hypoglycemia was observed with IDegAsp+IAsp vs IDet+IAsp. The most frequent adverse events in both groups were hypoglycemia, headache, and nasopharyngitis. Conclusions IDegAsp + IAsp was non-inferior to IDet+IAsp regarding HbA1c, had similar hypoglycemia rates and required fewer injections.
引用
收藏
页码:1263 / 1270
页数:8
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