Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

Takeda

Status and phase

Completed

Phase 3

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Alogliptin and voglibose

Study type

Interventional

Funder types

Industry

Identifiers

NCT01263509

U1111-1118-3992 (Registry Identifier)

SYR-322/OCT-003

Details and patient eligibility

About

The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on 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 and an α-glucosidase inhibitor, 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 completed a phase 2/3 α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).

Enrollment

179 patients

Sex

All

Ages

33 to 85 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).