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Abstract
In order to provide comprehensive information on the differences in bioactivity between human insulin and insulin analogues, published in vitro comparisons of human insulin and the rapid acting analogues insulin lispro (Humalog®), insulin aspart ( NovoRapid®), insulin glulisine (Apidra®), and the slow acting analogues insulin glargine (Lantus®), and insulin detemir (Levemir®) were gathered from the past 20 years (except for receptor binding studies). A total of 50 reports were retrieved, with great heterogeneity among study methodology. However, various differences in bioactivity compared to human insulin were obvious (e.g. differences in effects on metabolism, mitogenesis, apoptosis, intracellular signalling, thrombocyte function, protein degradation). Whether or not these differences have clinical bearings (and among which patient populations) remains to be determined.
Highlights
Since the first insulin derivatives were synthetised in the 1970s for scientific purposes [1,2], the therapeutic potential of these compounds for diabetic patients was already under investigation
Differences in metabolic activity There were 14 publications reporting in vitro studies on the metabolic activity of insulin analogues in comparison to synthetic human insulin. Aspart This issue was addressed in the Scientific Discussion of insulin aspart, published by the European Medicines Agency (EMEA)
Glargine This issue was addressed in the Scientific Discussion of insulin glargine, published by the EMEA
Summary
Since the first insulin derivatives were synthetised in the 1970s for scientific purposes [1,2], the therapeutic potential of these compounds for diabetic patients was already under investigation. In 1992 (when the carcinogenicity of B10Asp [4] was disclosed by haphazard) it was realized that manipulations of the insulin molecule could introduce the risk of artificial bioactivities into the treatment of diabetic patients [4,5,6]. Because of such concerns, insulin manufacturers subsequently favoured the design of derivatives (euphemistically called insulin analogues) with particular absorption properties (i.e. faster or more prolonged absorption from the subcutaneous tissue after injection [7,8]). Their biological potencies still remain to be fully elucidated [4]
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