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A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

NCT00857558 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2017-03-09

No results posted yet for this study

Summary

A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes

Conditions

  • Diabetes, Type 2

Interventions

DRUG

saxagliptin

orally administration at 1 mg once a day for 12 weeks

DRUG

saxagliptin

orally administration at 2.5 mg once a day for 12 weeks

DRUG

saxagliptin

orally administration at 5 mg once a day for 12 weeks

DRUG

placebo

orally administration once a day for 12 weeks

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuhisa Saito · OPC-J

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Japan

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Entities

Drugs

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 NCT00857558 on ClinicalTrials.gov