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

Institut for Klinisk Medicin

58 Citationer (Scopus)

48 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.

Originalsprog	Engelsk
Tidsskrift	Journal of Maternal - Fetal & Neonatal Medicine
Vol/bind	27
Udgave nummer	1
Sider (fra-til)	7-13
Antal sider	7
ISSN	1476-7058
DOI	https://doi.org/10.3109/14767058.2013.799650
Status	Udgivet - jan. 2014

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10.3109/14767058.2013.799650Licens: CC BY

A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetesForlagets udgivne version, 518 KBLicens: CC BY

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AU - Mathiesen, Elisabeth R

AU - Jovanovič, Lois

AU - McCance, David R

AU - Ivanisevic, Marina

AU - Durán-Garcia, Santiago

AU - Brøndsted, Lise

AU - Nazeri, Avideh

AU - Damm, Peter

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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.

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.

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KW - Gestational Age

KW - Humans

KW - Hypoglycemic Agents

KW - Insulin Aspart

KW - Insulin, Isophane

KW - Insulin, Long-Acting

KW - Live Birth

KW - Pregnancy

KW - Pregnancy Outcome

KW - Pregnancy in Diabetics

KW - Pregnancy, Ectopic

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DO - 10.3109/14767058.2013.799650

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JO - Journal of Maternal-Fetal Medicine

JF - Journal of Maternal-Fetal Medicine

IS - 1

ER -

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

Abstract

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