Phase 3 study update of linagliptin for the treatment of type 2 diabetes

Boehringer Ingelheim announced results from its Phase 3 studies of linagliptin for the treatment of type 2 diabetes. In the first study, linagliptin as monotherapy was administered to type 2 diabetes patients for whom metformin is inappropriate. In this study, statistically significant differences in HbA1c between linagliptin and placebo could be seen at week 6, and at week 18 the placebo adjusted mean difference was –0.57% (p<0.0001). Among patients who began the trial with an HbA1c of ≥ 7.0%, 23.5% taking linagliptin achieved HbA1c <7.0%, compared to 11.8% taking placebo. Linagliptin-treated patients also saw statistically significant reductions in fasting plasma glucose (FPG) levels compared to placebo (adjusted mean difference from baseline –20.5 mg/dl; p=0.0002). In a second study, when added to sulfonylurea (SU), treatment with linagliptin resulted in significant reductions in HbA1c from baseline (mean placebo adjusted HbA1c reduction –0.47%; p<0.0001). In addition, new pharmacokinetic (PK) data demonstrate that decreases in renal function had minor effect on the elimination of linagliptin.

Linagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor being developed as an oral once-daily tablet, as monotherapy and combination therapy, to treat type 2 diabetes.

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