Boehringer Ingelheim announced results from its four Phase 3 trials of linagliptin for the treatment of type 2 diabetes. The aim of the four, 24-week, international, randomized, double-blind, placebo-controlled studies was to assess the efficacy and safety profile of linagliptin (5 mg once-daily) versus placebo, administered over 24 weeks in patients with type 2 diabetes who were failing to achieve glycemic control (defined as HbA1c greater than or equal to 7.0 percent and less than or equal to 10.0 percent). The primary endpoint was the change in HbA1c from baseline to week 24. The studies assessed linagliptin as monotherapy (exercise and diet alone) (n=336 linagliptin, n=167 placebo), as add-on to metformin (n=523 linagliptin + metformin, n=177 placebo + metformin), as add-on to metformin plus a sulfonylurea (n=792 linagliptin + metformin + sulfonylurea, n=263 placebo + metformin + sulfonylurea), and as initial combination with pioglitazone (n=259 linagliptin +pioglitazone, n=130 placebo + pioglitazone).
In these four studies, statistically significant placebo-adjusted changes in HbA1c were observed with linagliptin (5 mg) monotherapy versus placebo (-0.69 percent, p<0.0001) and when used in combination with other commonly-used oral anti-diabetic drugs, including metformin (-0.64 percent, p<0.0001), metformin plus a sulfonylurea (-0.62 percent, p<0.0001), and as initial combination with pioglitazone (-0.51 percent, p<0.0001). Linagliptin therapy also resulted in improvements in beta-cell function. Declining beta-cell function is believed to be a key factor driving the progression of type 2 diabetes.
Linagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor formulated as an oral once-daily tablet, being developed as both monotherapy and combination therapy.
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