Results of a 102 week Phase III investigation for linagliptin (trade name Trajenta® in Europe) were announced today, and showed significant and durable reductions in blood glucose levels for adults who suffer from type 2 diabetes. The study which was presented at the 47th Annual Meeting of the European Association for the Study of Diabetes (EASD), demonstrated that the DPP-4 inhibitor linagliptin displayed a promising safety profile and reduced HbA1c levels by 0.8% over the long term in individuals treated with linagliptin for the entire investigation period.

Prof. David Owens, Clinical Professor of the Department of Medicine, Cardiff University School of Medicine, Wales, UK, explained:

“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. This is especially important in chronic conditions such as type 2 diabetes.”

The information from these patients reveal the effectiveness 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 HbA1c of 0.8% after 24 weeks of blinded treatment were observed to be durable over the further 78 weeks. In general, the rate of hypoglycemic events was low and body weight stayed the same.

Another 12-week investigation also revealed the effectiveness and tolerability of linagliptin as add-on therapy to metformin. In the test, patients with type 2 diabetes taking uncontrolled metformin twice daily (≥1500mg/day), where randomly split into two groups, one group received linagliptin 2.5mg twice daily (to enable integration with metformin twice daily dosing regimen during the 12 week investigation), and the other group received linagliptin 5mg approved doses once daily. Results revealed comparable placebo-adjusted HbA1c reductions of -0.74% and 0.8% respectively (from a mean baseline HbA1c of 8.0%, p

The information presented at EASD shows meaningful effectiveness of linagliptin with a good safety and tolerability profile across the full spectrum of type 2 diabetes, from patients who are newly diagnosed to those with severe renal impairment.

The results were announced by Boehringer Ingelheim and Eli Lilly and Company.

Written by Grace Rattue