Linagliptin (Trajenta®) achieves meaningful and durable reductions in blood glucose for adults with type 2 diabetes (T2D), according to the results of a Phase III study presented at the 47th Annual Meeting of the European Association for the Study of Diabetes (EASD).
In the 102-week study, the DPP-4 inhibitor linagliptin gave a favourable safety profile and lowered HbA1c levels by 0.8% over the long term in those patients treated with linagliptin for the full study period.
“These results show that the efficacy achieved by linagliptin is reliable and meaningful in a clinical setting, but also that it is durable over the long term,” said David Owens, Clinical Professor of the Department of Medicine at Cardiff University, Wales.
“This is especially important in chronic conditions such as type 2 diabetes,”
The data demonstrated the efficacy and tolerability of linagliptin as mono-, dual- (plus metformin or initial combination with pioglitazone) or triple (plus metformin and sulphonylurea) oral therapy over a period of 102 weeks.
Reductions in HbA1cof 0.8% after 24 weeks of blinded treatment were seen to be durable over the additional 78 weeks. Overall, the rate of hypoglycaemic events was low and body weight remained unchanged.
An additional 12-week study also indicated the efficacy and tolerability of linagliptin as add-on therapy to metformin.
In the trial, type 2 diabetes patients uncontrolled with metformin twice daily (≥1500mg/day) were randomised either to linagliptin 2.5mg twice daily (to enable integration with metformin twice daily dosing regimen during this 12-week-study) or linagliptin 5mg approved dose once daily.
Results showed comparable placebo-adjusted HbA1c reductions of -0.74% and 0.8% respectively (from a mean baseline HbA1c of 8.0%, p<0.0001).
“Linagliptin is a new treatment that is primarily excreted unmetabolised via the bile and gut, and so delivers reliable HbA1c reductions at one dosage strength for all patients, even for those with declining hepatic or renal function,” said Prof. Anthony Barnett, Consultant Physician at the Heart of England NHS Foundation Trust and Emeritus Professor of Medicine at the University of Birmingham, UK.
“One dosage strength for all patients will help make the process of prescribing easier and more straightforward for physicians.”
The drug received approval from both the European Medicines Agency and US Food and Drug Administration earlier this year.