Briefing note: linagliptin (Trajenta)

SMC accepted linagliptin for restricted use in the treatment of type 2 diabetes mellitus to improve
glycaemic control. It is restricted to use in combination with metformin, when diet and exercise plus
metformin alone do not provide adequate glycaemic control and the addition of a sulphonylurea
is inappropriate.

• 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.
   
• Linagliptin works by inhibiting DPP-4, an enzyme that breaks down two hormones involved in the regulation of blood sugar. This helps to lower blood sugar levels by stimulating insulin secretion from the pancreas and decreasing levels of glucagon (a hormone that raises blood sugar) in the circulation. It is given as a tablet.
   
• Studies have shown that linagliptin, in combination with metformin, controlled blood sugar as well as glimepiride plus metformin, and better than metformin plus placebo (a dummy medicine containing no active treatment).
   
• In the studies, fewer patients given linagliptin experienced side effects compared with patients given another medicine.
   
• SMC accepted linagliptin for restricted use in the treatment of type 2 diabetes mellitus because it was considered to offer value for money. SMC cannot recommend the use of linagliptin as monotherapy or in combination with metformin and a sulphonylurea as the company’s submission related only to its use in combination with metformin.