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

NCT01263496 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2012-02-03

Study results available
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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.

Conditions

Interventions

DRUG

Alogliptin

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

DRUG

Alogliptin

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

DRUG

Alogliptin

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

DRUG

Alogliptin

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

DRUG

Voglibose

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

Sponsors & Collaborators

Principal Investigators

  • Professor, Department of Medicine · Kawasaki Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
29 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-09-30
Completion
2008-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263496 on ClinicalTrials.gov