Boehringer Ingelheim Pharmaceuticals Press Release (06/09/12)
Boehringer Ingelheim and Eli Lilly presented results from a randomized phase III clinical trial and a post-hoc analysis for linagliptin at the American Diabetes Association (ADA) which showed that adults with type 2 diabetes being treated with linagliptin in combination with certain other diabetes therapies achieved clinically meaningful blood glucose control. The results of the phase III, 52-week study with 1,261 patients found that that linagliptin was effective as an add-on therapy to basal insulin alone, or in combination with metformin and/or pioglitazone, in reducing blood glucose levels in adult patients with type 2 diabetes, when compared to placebo. Those patients treated with linagliptin demonstrated a placebo-adjusted reduction in HbA1c of 0.65 percent from a baseline HbA1c of 8.3 percent at 24 weeks without weight gain or additional risk of hypoglycemia. In the post-hoc analysis of a second phase III trial it was found that hyperglycemic patients on a background of metformin randomized to add linagliptin were better able to achieve the target of HbA1c levels less than 7 percent without weight gain and/or hypoglycemia after 104 weeks than those randomized to take glimepiride, as well as achieving comparably improved blood glucose levels.