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Title: Alogliptin Alone and With Add-On, Reduces Hb A1C in Phase 3 Trials

"Alogliptin Alone and With Add-On, Reduces Hb A1C in Phase 3 Trials"

SAN FRANCISCO -- June 10, 2008 -- Results from 5 pivotal phase 3 studies of alogliptin were announced at the American Diabetes Association (ADA) 68th Scientific Session. Alogliptin, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4, is currently under investigation as an oral treatment for type 2 diabetes. Alogliptin administered once daily demonstrated statistically significant reductions in haemoglobin (Hb) A1C 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. Phase 3 studies were conducted in over 2,000 patients in 220 centres worldwide. All 5 phase 3 studies were randomised, double-blind, placebo-controlled studies, designed to assess the efficacy and safety of alogliptin alone, with metformin add-ons, and with sulfonylurea add-ons. The primary endpoint was change from baseline in Hb A1C at week 26 in the intent-to-treat population. Alogliptin was studied at 12.5 mg and 25 mg, once daily, in all studies. In all studies, except for the insulin add-on, mean baseline Hb A1C was between 7.9% and 8.1%, and mean duration of type 2 diabetes was between 6 to 8 years. In the insulin add-on, mean baseline Hb A1C was 9.3% and mean duration of type 2 diabetes was 13 years. The mean age of patients in all studies was between 53 and 57 years. In all 5 studies, the mean change from baseline Hb A1C levels were significantly greater for both 12.5 mg and 25 mg alogliptin doses versus placebo at the study's end. A greater percentage of patients achieved Hb A1C levels of less than or equal to 7% at both 12.5 mg and 25 mg alogliptin doses versus placebo, in the alogliptin monotherapy, then the metformin add-on studies, and finally, sulfonylurea add-on studies. The mean changes from baseline Hb A1C levels were similar regardless of age, body mass index (BMI), or ethnicity. Alogliptin was well-tolerated at all doses and in combination with other type 2 diabetes medications. Common adverse events were similar across groups in each study. "Almost half the patients with type 2 diabetes are not at the ADA recommended Hb A1C goal of less than 7%, 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, Diabetes & Metabolism Translational Medicine Unit, University of Vermont College of Medicine, Burlington, Vermont. "These clinical data show that alogliptin effectively reduces blood sugar in patients, alone or when used in combination with existing oral antidiabetic treatments as well as insulin, increasing the range of treatment options for patients." SOURCE: Takeda Pharmaceuticals North America

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