Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 480
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Voglibose intervention 6: Placebo
Intervention descriptions: intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks intervention 5: Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 6: Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.

Protocol document: