A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes
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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.
I: Journal of Maternal - Fetal & Neonatal Medicine, Bind 27, Nr. 1, 01.2014, s. 7-13.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 - Brøndsted, Lise
AU - Nazeri, Avideh
AU - Damm, Peter
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 - Abortion, Induced
KW - Abortion, Spontaneous
KW - Congenital Abnormalities
KW - Diabetes Mellitus, Type 1
KW - Drug Combinations
KW - Female
KW - Fetal Death
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
U2 - 10.3109/14767058.2013.799650
DO - 10.3109/14767058.2013.799650
M3 - Journal article
C2 - 23617228
VL - 27
SP - 7
EP - 13
JO - Journal of Maternal-Fetal Medicine
JF - Journal of Maternal-Fetal Medicine
SN - 1476-7058
IS - 1
ER -
ID: 138421739