This week at the 46 th Annual Meeting of the European Association for the Study of Diabetes (EASD) Boehringer Ingelheim presented data from its linagliptin (Tradjenta) phase III clinical trial. Linagliptin belongs to the novel class of DPP-4 inhibitors and is currently in late stage development as a once-daily, single-dose oral tablet.
The phase III data found that investigational linagliptin therapy resulted in significant reductions in blood sugar as measured by hemoglobin A1c (HbA1c) when compared to placebo, both when added to sulfonylurea in inadequately controlled type 2 diabetes (T2D) patients, and when administered as monotherapy in T2D patients for whom metformin is inappropriate. In addition, new pharmacokinetic (PK) data demonstrate that decreases in renal function had minor effect on the elimination of linagliptin. These findings support the study conclusion that a dose adjustment may not be required in T2D patients with varying degrees of renal impairment when treated with linagliptin.
Boehringer Ingelheim is filing linagliptin for market authorization in key countries across the globe in 2010 and is looking forward to making this novel treatment available to people with type 2 diabetes as soon as possible.
For the full press release click here.