linagliptin (Trajenta)

following a full submission

linagliptin film-coated tablet (Trajenta®) is accepted for restricted use within NHS Scotland.

Indication under review: The treatment of type 2 diabetes mellitus to improve glycaemic control in adults:

As monotherapy
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contra-indicated due to renal impairment.

As combination therapy
- in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
- in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

SMC restriction: in combination therapy with metformin when diet and exercise plus metformin alone does not provide adequate glycaemic control in patients for whom the addition of a sulphonylurea is inappropriate.

In two randomised double-blind, controlled studies, linagliptin in combination with metformin was found to be non-inferior to a sulphonylurea plus metformin, and superior to placebo plus metformin in controlling glycaemia, measured by the change in glycosylated haemoglobin (HbA1c).  Linagliptin was associated with similar rates of hypoglycaemia and changes in weight when compared with placebo.  Linagliptin is one of a number of medicines in this class, some of which are available at a lower acquisition cost.

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.