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June 9, 2008
By: Tim Wright
Editor-in-Chief, Contract Pharma
Takeda Global R&D Center reported results from five Phase III studies of alogliptin as an oral treatment for type 2 diabetes, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4). 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. In the alogliptin monotherapy study, a significantly greater percentage of patients achieved HbA1c levels of less than or equal to 7%. Similar results were seen in the add-on to metformin, thiazolidinedione and sulfonylurea studies. Across all studies, patients achieved significant reductions in HbA1c of as much as .80%, depending on alogliptin dose and treatment regimen. Greater HbA1c reductions were seen in patients with higher baseline HbA1c. Safety results showed that alogliptin was weight neutral and well tolerated in patients with type 2 diabetes, with an incidence of hypoglycemia similar to placebo.
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