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

NCT00997282 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2014-01-08

No results posted yet for this study

Summary

The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.

Conditions

  • Diabetes Type 2

Interventions

DRUG

OPC-262 2.5 mg

orally administered once daily for 24 weeks

DRUG

OPC-262 5 mg

orally administered once daily for 24 weeks

DRUG

Placebo

orally administered once daily for 24 weeks

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kaatsuhisa Saito · OPCJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Japan

More Related Trials

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 NCT00997282 on ClinicalTrials.gov