Archived: linagliptin (Trajenta)

following a full submission:

linagliptin (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 contraindicated due to renal impairment.

- as combination therapy

• in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products does not provide adequate glycaemic control.
• in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

SMC restriction:

• as monotherapy in patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance.
• as combination therapy with a sulphonylurea and metformin when diet and exercise plus dual therapy does not provide adequate glycaemic control.

Treatment with linagliptin reduces HbA1c levels significantly more than placebo when used as monotherapy or in combination with metformin and a sulphonylurea or in combination with insulin and/or metformin and/or pioglitazone. An indirect comparison demonstrated similar efficacy to another DPP-4 inhibitor.

SMC is unable to recommend the use of linagliptin in combination with insulin as the economic case has not been demonstrated.