Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes

The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

Diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). These complications are associated with reduced quality of life and increased morbidity and mortality.

Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus.

Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. This study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within Asia.

Participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.

• Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening.
• Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening.
• Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.

Inclusion Criteria:

• Has a historical diagnosis of Type 2 Diabetes Mellitus.
• Has a body mass index between acceptable range.
• Is experiencing inadequate glycemic control.
• Body weight keeps constant.
• Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.

Exclusion Criteria:

• Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
• Has a systolic blood pressure beyond the acceptable range at Screening visit.
• Has New York Heart Association Class III or IV heart failure regardless of therapy.
• Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
• Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.