Briefing note: exenatide (Bydureon)

SMC accepted exenatide once weekly for restricted use as third-line treatment of type 2 diabetes
mellitus in combination with:

- metformin
- sulphonylurea
- thiazolidinedione
- metformin and sulphonylurea
- metformin and thiazolidinedione

in adults who have not achieved adequate glycaemic control on maximally tolerated doses of
these oral therapies.

• Diabetes mellitus is a condition in which there is too much sugar present in the blood. Type 2 diabetes develops when the body does not make enough insulin (a hormone which helps sugar to be used by the body) or the insulin that is produced does not work properly. Keeping blood sugar levels as near to normal as possible reduces the risk of long-term diabetes complications such as heart disease, blindness, stroke and kidney failure.
   
• Exenatide is one of a new class of diabetes drugs that help to lower blood sugar levels by stimulating insulin secretion from the pancreas, curbing inappropriately elevated glucagon secretion (a hormone that raises blood sugar), and slowing the emptying of the stomach. It is injected under the skin once weekly.
   
• Exenatide, in an injection that is given twice daily, has previously been accepted by SMC for restricted use for the treatment of type 2 diabetes in combination with metformin and/or sulphonylureas and in combination with metformin and a thiazolidinedione as a third-line preinsulin treatment option. The current submission is for a new prolonged-release formulation of exenatide that allows once weekly administration.
   
• Four studies showed that exenatide given once weekly worked better than comparators in patients receiving oral anti-diabetic agents and/or diet and exercise regimens. In a fifth study, exenatide did not work better than a comparator.
   
• The most common side effects of exenatide were vomiting, upper respiratory tract infections, diarrhoea and constipation.
   
• SMC accepted exenatide for restricted use as third-line treatment in combination with a range of anti-diabetic medicines (metformin, sulphonylureas, thiazolidinediones, metformin plus sulphonylurea or metformin plus thiazolidinedione) because it offers value for money.