Cited by 383Diabetes and associated disordersDiabetes Management and ResearchT-cell and B-cell Immunology

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Nasal insulin to prevent type 1 diabetes in children with HLA genotypes and autoantibodies conferring increased risk of disease: a double-blind, randomised controlled trial

Näntö-Salonen, Kirsti, Kupila, Antti, Simell, Satu, Siljander, Heli, Salonsaari, Tiina, Hekkala, Anne, Korhonen, Sari, Erkkola, Risto, Sipilä, Jukka I, Haavisto, Lotta, Siltala, Marja, Tuominen, Juhani, Hakalax, Jari, Hyöty, Heikki, Ilonen, Jorma, Veijola, Riitta, Simell, Tuula, Knip, Mikael, Simell, Olli·2008·The Lancet

DOI 10.1016/s0140-6736(08)61309-4

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Abstract

Background In mouse models of diabetes, prophylactic administration of insulin reduced incidence of the disease. We investigated whether administration of nasal insulin decreased the incidence of type 1 diabetes, in children with HLA genotypes and autoantibodies increasing the risk of the disease. Methods At three university hospitals in Turku, Oulu, and Tampere (Finland), we analysed cord blood samples of 116 720 consecutively born infants, and 3430 of their siblings, for the HLA-DQB1 susceptibility alleles for type 1 diabetes. 17 397 infants and 1613 siblings had increased genetic risk, of whom 11 225 and 1574, respectively, consented to screening of diabetes-associated autoantibodies at every 3-12 months. In a double-blind trial, we randomly assigned 224 infants and 40 siblings positive for two or more autoantibodies, in consecutive samples, to receive short-acting human insulin (1 unit/kg; n=115 and n=22) or placebo (n=109 and n=18) once a day intranasally. We used a restricted randomisation, stratified by site, with permuted blocks of size two. Primary endpoint was diagnosis of diabetes. Analysis was by intention to treat. The study was terminated early because insulin had no beneficial effect. This study is registered with ClinicalTrials.gov, number NCT00223613. Findings Median duration of the intervention was 1.8 years (range 0-9.7). Diabetes was diagnosed in 49 index children randomised to receive insulin, and in 47 randomised to placebo (hazard ratio [HR] 1.14; 95% C…

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Authors: Näntö-Salonen, K., Kupila, A., Simell, S., Siljander, H., Salonsaari, T., Hekkala, A., Korhonen, S., Erkkola, R., Sipilä, J. I., Haavisto, L., Siltala, M., Tuominen, J., Hakalax, J., Hyöty, H., Ilonen, J., Veijola, R., Simell, T., Knip, M., & Simell, O.
Affiliations: University of Turku (FI)
University of Helsinki (FI)
Tampere University Hospital (FI)
University of Oulu (FI)
Tampere University (FI)
ORCID: Siljander, Heli
Hekkala, Anne
Erkkola, Risto
Haavisto, Lotta
Hyöty, Heikki
Ilonen, Jorma
Veijola, Riitta
Knip, Mikael
Venue: The Lancet
Publisher: Elsevier BV
Published: 2008-11
Volume: 372
Issue: 9651
Pages: 1746-1755
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(08)61309-4
OpenAlex: W2157440365
Cited by: 382
References: 32
Citations by year: 2026: 3 · 2025: 10 · 2024: 19 · 2023: 15 · 2022: 16 · 2021: 21 · 2020: 19 · 2019: 16 · 2018: 19 · 2017: 8 · 2016: 21 · 2015: 33 · 2014: 19 · 2013: 36 · 2012: 30
FWCI: 18.28
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
doi.org/10.15223/policy-017 (stm-asf)
doi.org/10.15223/policy-037 (stm-asf)
doi.org/10.15223/policy-012 (stm-asf)
doi.org/10.15223/policy-029 (stm-asf)
doi.org/10.15223/policy-004 (stm-asf)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
Keywords: type 1 diabetes prevention, nasal insulin, diabetes-associated autoantibodies, high genetic risk, children, siblings, diabetes onset, diabetes screening, cord blood screening, early trial termination, diabetic mouse model, insulin resistance index
MeSH terms: Administration, Intranasal, Autoantibodies, Child, Child, Preschool, Diabetes Mellitus, Type 1, Double-Blind Method, Female, Finland, Genetic Testing, Genotype, HLA-DQ Antigens, Humans, Hypoglycemic Agents, Infant, Infant, Newborn, Insulin, Male, Risk Factors, HLA-DQ beta-Chains

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Nasal insulin to prevent type 1 diabetes in children with HLA genotypes and autoantibodies conferring increased risk of disease: a double-blind, randomised controlled trial

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