Trajenta (linagliptine) belongs to the group of dipeptidyl peptidase-4 (DPP-4) inhibitors for treatment of type 2-diabetes. It is approved for monotherapy for patients who do not tolerate metformin or where metformin is contraindicated because of decreased kidney function. Furthermore it is approved in combination with metformin or as a supplement to metformin + sulphonylurea (SU) when these substances do not provide sufficient glycemic control.
The dose is 5 mg (1 tablet) once a day.
The efficacy of linagliptin was investigated in four randomized, double-blinded clinical studies of 24 weeks.
In addition a single long-term study of two years duration was carried out with glimperide (SU) as an active comparator. This study is not published.
In all studies the primary endpoint was a difference in HbA1c.
None of the studies compared linagliptine with other DPP-4 inhibitors. In general there were very few elderly patients >75 years included.
Linagliptine reduced HbA1c significantly more than placebo in all four studies.
However, linagliptine was not significantly better than glimeperide and pioglitazone.
The difference in HbA1c between linaglutin and placebo varied from -0.50 to -0.69.
Linagliptine had, as the rest of the DPP-4 inhibitors, very few adverse effects and was not associated with weight gain. The most frequently reported adverse effect concerning linagliptine was hypoclycemia, which occurred in mild to moderate cases.
Treatment with linagliptine for one month costs approximately 420 Dkr. corresponding to 13.99 Dkr. per. day.
- Experience with long-term treatment with DPP-4 inhibitors is limited.
- There are no comparative studies with the different DPP-4 inhibitors.
- There is no evidence of effect on clinically relevant endpoints such as micro- and macrovascular complications and mortality.
- Linagliptine can be used by people who cannot tolerate metformine, eg. because of decreased renal function.
Linagliptine was marketed on October 3rd 2011.
It is subject to reimbursement.