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Schmid, V. ; Kullmann, S. ; Gfrörer, W.* ; Hund, V.* ; Hallschmid, M. ; Lipp, H.P.* ; Häring, H.-U. ; Preissl, H. ; Fritsche, A. ; Heni, M.

Safety of intranasal human insulin: A review.

Diabetes Obes. Metab. 20, 1563-1577 (2018)
Postprint DOI PMC
Open Access Green
Aims: To conduct a review in order to assess the safety of intranasal human insulin in clinical studies as well as the temporal stability of nasal insulin sprays. Material and methods: An electronic search was performed using MEDLINE. We selected original research on intranasal human insulin without further additives in humans. The studies included could be of any design as long as they used human intranasal insulin as their study product. All outcomes and adverse side effects were extracted. Results: A total of 38 studies in 1092 individuals receiving acute human intranasal insulin treatment and 18 studies in 832 individuals receiving human intranasal insulin treatment lasting between 21 days and 9.7 years were identified. No cases of symptomatic hypoglycaemia or severe adverse events (AEs) were reported. Transient local side effects in the nasal area were frequently experienced after intranasal insulin and placebo spray, while other AEs were less commonly reported. There were no reports of participants being excluded as a result of AEs. No instances of temporal stability of nasal insulin were reported in the literature. Tests on insulin that had been repacked into spray flasks showed that it had a chemical stability of up to 57 days. Conclusions: Our retrospective review of published studies on intranasal insulin did not reveal any safety concerns; however, there were insufficient data to ensure the long-term safety of this method of chronic insulin administration. Improved insulin preparations that cause less nasal irritation would be desirable for future treatment.
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Publication type Article: Journal article
Document type Scientific Article
Corresponding Author
Keywords Database Research ; Insulin Resistance ; Obesity Therapy; Cell-line Thp-1; In-vitro; Hacat Keratinocytes; Alkaloid Berberine; Dendritic Cells; Injury; Skin; Sensitization; Expression; Toxicity
ISSN (print) / ISBN 1462-8902
e-ISSN 1463-1326
Journal Diabetes, Obesity and Metabolism
Quellenangaben Volume: 20, Issue: 7, Pages: 1563-1577 Article Number: , Supplement: ,
Publisher Wiley
Publishing Place Elsevier House, Brookvale Plaza, East Park Shannon, Co, Clare, 00000, Ireland
Non-patent literature Publications
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research and Metabolic Diseases (IDM)