Briefing Note: saxagliptin (Onglyza)

SMC accepted saxagliptin for the treatment of type 2 diabetes mellitus in adult patients as add-on combination therapy with metformin, when metformin together with diet and exercise does not provide adequate glycaemic (blood sugar) control. Saxagliptin is restricted for use in patients only when the addition of sulphonylureas is not appropriate, and represents an alternative to other agents such as thiazolidinediones.

• 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 longterm diabetes complications such as heart disease, blindness, stroke and kidney failure.
• Saxagliptin is one of a new class of oral antidiabetic agents known as dipeptidyl peptidase-4 inhibitors or incretin enhancers. Incretin hormones, such as glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), stimulate the release of the hormone insulin. In type 2 diabetes, incretin function is damaged and patients are unable to properly regulate their blood sugar levels. Medicines in this new class are expected to produce a more sustained effect on glucose control. Saxagliptin is taken as a tablet once daily.
• In two randomised controlled studies, saxagliptin was as effective as another dipeptidyl peptidase-4 inhibitor in reducing glycated haemoglobin (average blood glucose level over the past 2–3 months). In addition, saxagliptin had little effect on mean body weight.
• Saxagliptin was generally well tolerated, with side effects of infection and hypoglycaemia reported in both treatment groups. No cardiovascular side effects were reported in the saxagliptin group.
• SMC accepted saxagliptin for restricted use because it was considered to offer value for money.