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Alogliptin Phase 3 Study Design

Phase 3 studies were conducted in over 2,000 patients in 220 centers worldwide. All five phase 3 studies were randomized, double blind, placebo-controlled studies, designed to assess the efficacy and safety of alogliptin, alone or when added to another type 2 diabetes medication: metformin, pioglitazone, insulin or glyburide. The primary end point was change from baseline in HbA1c at week 26 (or last observation) 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 HbA1c was between 7.9 percent and 8.1 percent, and mean duration of type 2 diabetes was between six to eight years. In the insulin add-on, mean baseline HbA1c was 9.3 percent and mean duration of type 2 diabetes was 13 years. Mean age, in all studies, was between 53 and 57 years.

About Hemoglobin A1c (HbA1c)

HbA1c is a measure of an individual's average blood sugar over a three-month period. The ADA has recommended a target HbA1c level of <7 percent. ADA guidelines recommend clinical intervention for HbA1c >8 percent and to be considered for HbA1c between 7 and 8 percent.

About Alogliptin

Alogliptin, previously known by the development code SYR-322, is a selective DPP-4 inhibitor and is under investigation for the treatment of type 2 diabetes. Alogliptin was designed by Takeda to selectively inhibit DPP-4 and not other closely related proteins that are associated with other biologic activity. In in vitro studies, alogliptin has been shown to be 10,000-fold more selective for DPP-4 over other closely related proteins.

DPP-4 inhibitors are a new class of oral agents for the treatment of type 2 diabetes that block the degradation of incretin hormones, GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretin hormones are normally released in t
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