Boehringer Ingelheim Announces Pivotal Phase III Data Showing Linagliptin Reduced Blood Sugar Compared to Placebo in People With Type 2 Diabetes
ORLANDO, Fla., June 26 /PRNewswire/ -- 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),(1-4) fasting plasma glucose (FPG)(1-4) and postprandial glucose (PPG).(1,2) 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)(1) and when used in combination with other commonly-used oral anti-diabetic drugs, including metformin (-0.64 percent, p<0.0001),(2) metformin plus a sulfonylurea (-0.62 percent, p<0.0001),(3) and as initial combination with pioglitazone (-0.51 percent, p<0.0001).(4) Linagliptin therapy also resulted in improvements in beta-cell function.(1) Declining beta-cell function is believed to be a key factor driving the progression of type 2 diabetes.(5)
"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."