Boehringer Ingelheim/Eli Lilly's Trajenta (linagliptin) has been launched in the UK as a single-dose (5mg), once-daily tablet for the treatment of adults with type 2 diabetes mellitus (T2DM).
This new dipeptidyl peptidase-4 (DPP-4) inhibitor offers all the advantages of the existing DPP-4 inhibitor class but is the only diabetes treatment approved as once-daily and as a one-dose strength for all adult patients, say the companies.
Linagliptin is the only DPP-4 inhibitor primarily excreted via the bile, and the first treatment in this class licensed for use in T2DM irrespective of degree of renal impairment, with no dose adjustment or additional treatment-related monitoring required, they note. Around one-third of people with diabetes are affected by chronic kidney disease, one of the wide-ranging micro- and macrovascular complications associated with the disease.
Trajenta is licensed for adults with T2DM:
- 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;
- in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and
- in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Professor Anthony Barnett, consultant physician and emeritus professor of medicine, Heart of England NHS Foundation Trust and University of Birmingham, described the UK launch of Trajenta as "an important advance."
"Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function. Renal impairment is common in people with type to diabetes so this latter point is extremely important," he said.
In clinical trials involving over 4,000 patients, linagliptin delivered significant glycated hemoglobin (HbA1C) reductions compared to placebo and was generally well-tolerated. A mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add-on to metformin and a sulphonylurea.
"From a medicines management perspective, a treatment that is found in studies to be generally well-tolerated and can be prescribed regardless of a patient's kidney function offers healthcare professionals a valuable new choice in the management of diabetes," added Alia Gilani, a Glasgow pharmacist with a special interest in diabetes.
- New epidemiological research investigating T2DM prescribing trends in people with and without renal impairment reveals wide variations that may, say the authors, indicate a lack of therapeutic choice for renally-impaired patients.
The STARDUST (Study of the Treatment and Prevalence of Renal Disease in UK Diabetes Mellitus Type 2 Patients), which was presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in Portugal this month, found that 76% of eligible patients had renal impairment and that such patients were more likely to receive prescriptions of glucose-lowering treatments than patients without impairment.
The data showed that, contradictory to guidance from the National Institute for Health and Clinical Excellence (NICE), metformin prescribing remains common in T2DM patients with moderate and severe renal impairment, and that metformin prescribing rates in patients with renal impairment were higher compared to patients without renal impairment.
Sulphonylurea and insulin prescriptions were also found to be more common in patients with renal impairment and that, given similar duration of diabetes, prescriptions of insulin were two and a half times more common in patients with renal impairment versus the comparator arm.