Phase III clinical trials: Linagliptin achieves significant, sustained reductions in blood sugar

Jun 28 2010

Data from four pivotal Phase III clinical trials demonstrate that linagliptin achieved statistically significant and sustained reductions in blood sugar as measured by hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and postprandial glucose (PPG).  Boehringer Ingelheim Pharmaceuticals, Inc. is investigating the dipeptidyl peptidase 4 (DPP-4) inhibitor as an oral once-daily tablet, as monotherapy and combination therapy, to treat type 2 diabetes. The linagliptin data are being presented this week at the 70th Annual American Diabetes Association (ADA) Scientific Sessions in Orlando, Fla.

In the Phase III 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.

"It is imperative that blood sugar levels in people with type 2 diabetes are adequately controlled," said Dr. Giora Davidai, executive director & medical leader, medical affairs, cardiovascular & metabolic medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "Uncontrolled blood sugar puts type 2 diabetes patients at a higher risk of developing serious complications like renal impairment and cardiovascular disease, which are very common in patients with type 2 diabetes."

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, which is consistent with existing data showing that linagliptin may have a primarily non-renal route of excretion.

Two additional linagliptin studies conducted in Japanese patients also were presented at ADA.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.