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Cited by 100Gestational Diabetes Research and ManagementPregnancy and Medication ImpactDiabetes Management and Research

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

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Hod, Moshe, Mathiesen, Elisabeth R., Jovanovič, Lois, McCance, David R., Ivanisevic, Marina, Durán-Garcia, Santiago, Brøndsted, Lise, Nazeri, Avideh +1 more·2014·The Journal of Maternal-Fetal & Neonatal Medicine
DOI 10.3109/14767058.2013.799650PMC PMC3862070
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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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  • The safety of the use of aspart and detemir analogs was confirmed in randomized trials.

    “The safety of the use of aspart and detemir analogs was confirmed in randomized trials [104,105,106]”

    From Gestational Diabetes Mellitus—Recent Literature Review (2022) · cites this paper as [104]

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Research works printed but not linked: 24

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Authors
Hod, M., Mathiesen, E. R., Jovanovič, L., McCance, D. R., Ivanisevic, M., Durán-Garcia, S., Brøndsted, L., Nazeri, A., & Damm, P.
Affiliations
  • Tel Aviv University (IL)
  • University of Copenhagen (DK)
  • Sansum Diabetes Research Institute (US)
  • Royal Victoria Hospital (GB)
  • Hospital Universitario de Valme (ES)
  • Novo Nordisk (Denmark) (DK)
Corresponding author
Hod, Moshe
ORCID
Venue
The Journal of Maternal-Fetal & Neonatal Medicine
Publisher
Informa UK Limited
Published
2013-06-05
Volume
27
Issue
1
Pages
7-13
ISSN
  • 1476-4954 (ISSN-L)
  • 1476-7058
DOI
10.3109/14767058.2013.799650
PMC
PMC3862070
OpenAlex
W2094987273
Cited by
100
References
3
Citations by year
2026: 3 · 2025: 1 · 2024: 3 · 2023: 8 · 2022: 9 · 2021: 9 · 2020: 5 · 2019: 10 · 2018: 12 · 2017: 6 · 2016: 13 · 2015: 14 · 2014: 4 · 2013: 2 · 2012: 1
FWCI
12.34
Type
journal article
Language
en
Open access
Locations
  • The Journal of Maternal-Fetal & Neonatal Medicine (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
Funders
  • Novo Nordisk
  • Novo Nordisk Fonden (NNF14OC0009275)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
insulin detemir, type 1 diabetes in pregnancy, insulin aspart, perinatal outcomes, gestational age at delivery, fetal death, perinatal death, congenital malformations, insulin safety, obstetric outcomes
MeSH terms
Congenital Abnormalities, Abortion, Spontaneous, Abortion, Induced, Insulin Detemir, Diabetes Mellitus, Type 1, Drug Combinations, Female, Fetal Death, Gestational Age, Humans, Hypoglycemic Agents, Insulin, Isophane, Pregnancy, Pregnancy in Diabetics, Pregnancy Outcome, Pregnancy, Ectopic, Insulin, Long-Acting, Live Birth, Insulin Aspart

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