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Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

NCT01263470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2012-02-03

Study results available
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Summary

The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Alogliptin

Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks

DRUG

Alogliptin

Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

Alogliptin

Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

Alogliptin

Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks

DRUG

Voglibose

Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.

DRUG

Placebo

Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Professor, Department of Medicine · Kawasaki Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

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 NCT01263470 on ClinicalTrials.gov