Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan

Takeda

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Voglibose; Drug: Alogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01263496

SYR-322/OCT-001

U1111-1118-4027 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 438 patients

Sex: All

Ages: 29 to 87 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion criteria

• Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
• Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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438 participants in 5 patient groups

Alogliptin 6.25 mg QD

Experimental group

Treatment:

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Alogliptin 12.5 mg QD

Experimental group

Treatment:

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Alogliptin 25 mg QD

Experimental group

Treatment:

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Alogliptin 50 mg QD

Experimental group

Treatment:

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Drug: Alogliptin

Voglibose 0.2-mg TID

Active Comparator group

Treatment:

Drug: Voglibose