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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alogliptin 6.25 mg QD

Group Type EXPERIMENTAL

Alogliptin

Intervention Type DRUG

Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.

Alogliptin 12.5 mg QD

Group Type EXPERIMENTAL

Alogliptin

Intervention Type DRUG

Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.

Alogliptin 25 mg QD

Group Type EXPERIMENTAL

Alogliptin

Intervention Type DRUG

Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.

Alogliptin 50 mg QD

Group Type EXPERIMENTAL

Alogliptin

Intervention Type DRUG

Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.

Voglibose 0.2-mg TID

Group Type ACTIVE_COMPARATOR

Voglibose

Intervention Type DRUG

Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.

Interventions

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Alogliptin

Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.

Intervention Type DRUG

Alogliptin

Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.

Intervention Type DRUG

Alogliptin

Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.

Intervention Type DRUG

Alogliptin

Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.

Intervention Type DRUG

Voglibose

Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.

Intervention Type DRUG

Other Intervention Names

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SYR-322 SYR-322 SYR-322 SYR-322 Voglib BASEN®

Eligibility Criteria

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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).

Minimum Eligible Age

29 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No