TY - JOUR
T1 - A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes
AU - Hod, Moshe
AU - Mathiesen, Elisabeth R.
AU - Jovanovič, Lois
AU - McCance, David R.
AU - Ivanisevic, Marina
AU - Durán-Garcia, Santiago
AU - Brondsted, Lise
AU - Nazeri, Avideh
AU - Damm, Peter
N1 - Funding Information:
M.H., S.D.G. and M.I. have no conflicts of interest. E.R.M. is a member of an international scientific advisory board and has received fees for giving talks for Novo Nordisk. D.R.M. is a member of an international scientific advisory board, contributed to advisory committees and has received honoraria from Novo Nordisk in the past for giving lectures. P.D. and L.J. are members of an international scientific advisory board for Novo Nordisk. L.B. is an employee of Novo Nordisk and owns stocks in the company. A.N. is an employee of Novo Nordisk. Presented at meetings of the 6th International Symposium on Diabetes and Pregnancy, Salzburg, Austria, 23–26 March 2011; the 71st Scientific Sessions of the American Diabetes Association, San Diego, CA, USA, 24–28 June 2011; the 47th European Association for the Study of Diabetes Annual Meeting, Lisbon, Portugal, 12–16 September 2011. The maternal outcome results of this trial have been published [16]. This study was funded by Novo Nordisk. Editorial assistance for this manuscript was also funded by Novo Nordisk. ClinicalTrials.gov number NCT00474045. A list of trial sites are included in Supplement S5.
PY - 2014/1
Y1 - 2014/1
N2 - 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.
AB - 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.
KW - Congenital malformations
KW - Insulin detemir
KW - Perinatal outcomes
KW - Pregnancy
KW - Type 1 diabetes
UR - http://www.scopus.com/inward/record.url?scp=84889651836&partnerID=8YFLogxK
U2 - 10.3109/14767058.2013.799650
DO - 10.3109/14767058.2013.799650
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AN - SCOPUS:84889651836
SN - 1476-7058
VL - 27
SP - 7
EP - 13
JO - Journal of Maternal-Fetal and Neonatal Medicine
JF - Journal of Maternal-Fetal and Neonatal Medicine
IS - 1
ER -
