Validation of the glucose lowering capability for an innovative fast acting monomeric Insulin

When a person has diabetes, either their pancreas does not produce the insulin they need (type
1 diabetes) or their body does not make enough or cannot make effective use of the insulin
they produce (type 2 diabetes). Two types of insulin are currently marketed, the first is a
readily absorbed, rapid onset product intended to supply the bulk level of insulin needed after
a meal; the second type is released slowly and is intended to supply a background level of
insulin for the day. A long acting insulin has six insulin molecules tightly packed together
whereas the rapid insulin is just a single entity, and therefore can act quicker. A recent report
in the British Medical Journal indicated that 80% of Insulin used in the UK is rapid acting
insulin and although it has a superior safety profile, it is up to 5 x more expensive than long
acting insulin. Arecor have developed a lab scale manufacturing process whereby long acting
insulin can be converted to the rapid acting form. The approach is simple but has not been
developed previously because rapid acting insulin derived from the conventional material is
not stable; it breaks down when stored at high temperatures. Arecor’s proprietary protein
stabilising technology, Arestat®, has been applied to produce a stable rapid acting insulin that
does not break down during storage and at high temperatures. Insulin pens that are currently
used only last a short time before the insulin breaks down. The objective of this study is to
demonstrate that the low cost product developed by Arecor has the same glucose lowering
kinetics as other rapid acting insulins. With the worldwide diabetic population set to grow
from 285 million to 438 million by 2030, a cost effective insulin product comparable in
performance to the market leading rapid acting insulins will offer substantial savings to the
NHS and be competitive in emerging markets.