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Boehringer Ingelheim Announces Pivotal Phase III Data Showing Linagliptin Reduced Blood Sugar Compared to Placebo in People With Type 2 Diabetes
Date:6/26/2010

Notably, in these trials in type 2 diabetes patients with mild and moderate renal impairment, linagliptin blood plasma levels were comparable to those seen in type 2 diabetes patients with normal renal function,(1) which is consistent with existing data showing that linagliptin may have a primarily non-renal route of excretion.(6)

Two additional linagliptin studies conducted in Japanese patients also were presented at ADA. (7,8)

About the linagliptin pivotal Phase III trials(1-4)

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).

Safety data and additional results from the pivotal trials

  • Patients who received linagliptin monotherapy were significantly more likely to achieve a reduction in HbA1c greater than or equal to 0.5 percent at 24 weeks than placebo (47.1 percent versus 19.0 percent).  The greatest placebo-adjusted changes in HbA1c  (-1.01 percent, p< 0.001) were
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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