Linagliptin demonstrates durable reductions in blood glucose for T2D adults

Sep 16 2011

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced results of a 102 week Phase III study for linagliptin (trade name Trajenta® in Europe), which show meaningful and durable reductions in blood glucose for adults with type 2 diabetes (T2D). In the two-year study presented today at the 47^th Annual Meeting of the European Association for the Study of Diabetes (EASD), the DPP-4 inhibitor linagliptin showed 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.

“One dosage strength for all patients will help make the process of prescribing easier and more straightforward for physicians.”

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

The data from these patients demonstrate 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 HbA1c of 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, Heart of England NHS Foundation Trust and Emeritus Professor of Medicine, University of Birmingham, UK. "One dosage strength for all patients will help make the process of prescribing easier and more straightforward for physicians."

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