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

Moshe Hod; Elisabeth R Mathiesen; Lois Jovanovič; David R McCance; Marina Ivanisevic; Santiago Durán-Garcia; Lise Brøndsted; Avideh Nazeri; Peter Damm

doi:10.3109/14767058.2013.799650

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

Moshe Hod, Elisabeth R Mathiesen, Lois Jovanovič, David R McCance, Marina Ivanisevic, Santiago Durán-Garcia, Lise Brøndsted, Avideh Nazeri, Peter Damm

Department of Clinical Medicine

Research output: Contribution to journal › Journal article › Research › peer-review

86 Citations (Scopus)

190 Downloads (Pure)

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.

Original language	English
Journal	Journal of Maternal - Fetal & Neonatal Medicine
Volume	27
Issue number	1
Pages (from-to)	7-13
Number of pages	7
ISSN	1476-7058
DOIs	https://doi.org/10.3109/14767058.2013.799650
Publication status	Published - Jan 2014

Keywords

Abortion, Induced
Abortion, Spontaneous
Congenital Abnormalities
Diabetes Mellitus, Type 1
Drug Combinations
Female
Fetal Death
Gestational Age
Humans
Hypoglycemic Agents
Insulin Aspart
Insulin, Isophane
Insulin, Long-Acting
Live Birth
Pregnancy
Pregnancy Outcome
Pregnancy in Diabetics
Pregnancy, Ectopic

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A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. / Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois; McCance, David R; Ivanisevic, Marina; Durán-Garcia, Santiago; Brøndsted, Lise; Nazeri, Avideh; Damm, Peter.

In: Journal of Maternal - Fetal & Neonatal Medicine, Vol. 27, No. 1, 01.2014, p. 7-13.

Research output: Contribution to journal › Journal article › Research › peer-review

Hod, Moshe ; Mathiesen, Elisabeth R ; Jovanovič, Lois ; McCance, David R ; Ivanisevic, Marina ; Durán-Garcia, Santiago ; Brøndsted, Lise ; Nazeri, Avideh ; Damm, Peter. / A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. In: Journal of Maternal - Fetal & Neonatal Medicine. 2014 ; Vol. 27, No. 1. pp. 7-13.

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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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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.

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