Along-term Study of OPC-262 in Patients With Type 2 Diabetes

NCT ID: NCT01634282

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-06-30

Brief Summary

The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262

Conditions

Diabetes, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPC-262

Group Type: EXPERIMENTAL

OPC-262

Intervention Type: DRUG

Orally administered once daily

Interventions

OPC-262

Orally administered once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24）
• Patients who are capable of giving informed consent prior to participating in this clinical study
• Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria

• Patients who withdrew from Study 262-09-001
• Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001
• Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study
• Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study
• Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Kansai Region, , Japan

Kanto Region, , Japan

Kyushu Region, , Japan

Shikoku Region, , Japan

Tohoku Region, , Japan

Countries

Japan

Other Identifiers

262-09-002

Identifier Type: -

Identifier Source: org_study_id