A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

Abstract

ObjectiveThis randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented.MethodsSubjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8–12 gestational weeks.ResultsFor IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children from the IDet arm than the NPH arm (treatment difference: 0.49 weeks [95% CI 0.11;0.88], p = 0.012, linear regression). Sixteen children had a malformation (IDet: n = 8/142, 5.6%; NPH: n = 8/145, 5.5%). The incidence of adverse events was similar between treatments.ConclusionIDet is as well tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified.

Pregnancy and neonatal outcomes in women with type 1 diabetes mellitus

“…Its frequency throughout the world is about 60 % (14,15), and the highest one is reported in Italy (73 %) (16). The frequency of caesarean section in our department during study period was 78 %, but in the years 1994-2000 it was only 37.2 % (17).…”

Detemir potential applications in the treatment of diabetes during pregnancy: proven benefits and perspectives

“…Detemir was shown to have a lower IGF-1 receptor affinity and, therefore, lower mitogenic potential compared with human insulin [82]. This suggested its safety in terms of teratogenesis, which was confirmed by the data of a recently published clinical trial involving 470 women with T1D [83]. …”

Systematic Literature Review of Basal Bolus Insulin Analogue Therapy during Pregnancy

“…The only statistically significant finding was a lower mean fasting glucose in the detemir group [57,58]. The limited body of data on detemir use during pregnancy thus prohibits us from drawing conclusions.…”

“…A large open-label, randomized, parallel-group study of women with T1DM had results published by Mathieson et al & Hod et al [57,58] (see Table 5a & 5b). Patients were randomized to detemir (n=152) or NPH (n=158) up to 12 months preconception or at 8-12 weeks' gestational age and continued until 6 weeks postpartum.…”

“…Lispro has the potential to pass via the placenta if it forms immune complexes with immunoglobulins. However, Jovanovic et al [20] have shown no placental transfer via umbilical blood samples following intravenous administration of lispro during labor and similarly, Holcberg et al [60] conducted an in vitro perfusion study that demonstrated no lispro in the umbilical cord [20,58,59]. …”