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Randomized Controlled Trial
. 2014 Jan;27(1):7-13.
doi: 10.3109/14767058.2013.799650. Epub 2013 Jun 5.

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

Moshe Hod  1 , Elisabeth R Mathiesen, Lois Jovanovič, David R McCance, Marina Ivanisevic, Santiago Durán-Garcia, Lise Brøndsted, Avideh Nazeri, Peter Damm
Affiliations
Free PMC article
Randomized Controlled Trial

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

Moshe Hod et al. J Matern Fetal Neonatal Med. 2014 Jan.
Free PMC article

Abstract

Objective: This 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.

Methods: Subjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks.

Results: For 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.

Conclusion: IDet is as well tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified.

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References

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