A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes

NCT ID: NCT01193179

Last Updated: 2014-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent

Detailed Description

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Conditions

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Diabetes, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OPC-262

Group Type EXPERIMENTAL

OPC-262

Intervention Type DRUG

Oral administration of tablets for 52 weeks

Interventions

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OPC-262

Oral administration of tablets for 52 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\) Patients who are capable of giving informed consent
* 2\) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion Criteria

* Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kanto Rigeon, , Japan

Site Status

Kinki Region, , Japan

Site Status

Kyushu Region, , Japan

Site Status

Tohoku Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JapicCTI-101252

Identifier Type: OTHER

Identifier Source: secondary_id

262-10-005

Identifier Type: -

Identifier Source: org_study_id

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