Maternal blood glucose level during gestation
is crucial for normal foetal development. In the non- clinical studies in non-diabetic
rats required by authorities, long-acting insulin analogous being developed to
decrease blood glucose levels persistently generate safety data on
embryo-foetal effects, which may be challenging to interpret.
Separating potential toxicological effects of
the insulin analogue from those caused by the
hypoglycaemia becomes problematic, when the effects of the latter are unknown.
Therefore, the aim of the present study was to
investigate foetal effects of persistent maternal hypoglycaemia in rats after
continuous maternal insulin-infusion throughout gestation. Effects on foetal
size were measured and foetal skeletons were examined after alizarin red and
alcian blue staining.
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