Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 438
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.

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, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).

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

Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Voglibose
Intervention descriptions: intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. intervention 5: Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.

Protocol document: