Phase 3 Results for Alogliptin Demonstrated Significant Blood Sugar Reductions in Monotherapy and Four Add-on Thera...( Data from five pivotal phase 3 studi...),Health

Data from five pivotal phase 3 studies presented at the American Diabetes

Association 68th Scientific Sessions

SAN FRANCISCO, June 7 /PRNewswire/ -- Results from five pivotal phase 3 studies of alogliptin were announced today at the American Diabetes Association (ADA) 68th Scientific Sessions by Takeda Global Research & Development Center, Inc. Alogliptin, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4), is currently under investigation as an oral treatment for type 2 diabetes. Alogliptin administered once daily demonstrated statistically significant reductions in hemoglobin A1c (HbA1c) versus placebo as a monotherapy and as an add-on therapy with the major classes of type 2 diabetes medications: metformin, thiazolidinediones, insulin and sulfonylureas.

"Almost half the patients with type 2 diabetes are not at the American Diabetes Association recommended HbA1c goal of less than 7 percent, so it's important to have new treatment options that are both effective and well tolerated to potentially address the large number of patients who aren't adequately controlled," said Richard Pratley, MD, director of the Diabetes & Metabolism Translational Medicine Unit at the University of Vermont College of Medicine. "These clinical data show that alogliptin effectively reduces blood sugar in patients, alone or when used in combination with existing oral anti-diabetic treatments as well as insulin, increasing the range of treatment options for patients."

In the alogliptin monotherapy study, a significantly greater percentage of patients achieved HbA1c levels of less than or equal to 7 percent. Similar results were seen in the add-on to metformin, thiazolidinedione and sulfonylurea studies. Across all studies, patients achieved significant reductions in HbA1c, up to 0.80 percent, depending on the alogliptin dose and their treatment regimen. Greater HbA1c reductions were seen in patients with h
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