A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)

Kyowa Kirin Co., Ltd.0 sites222 target enrollmentAugust 2009

ConditionsDiabetes, Type 2

InterventionsOPC-262

DrugsOPC-262

Overview

Phase: Phase 3
Intervention: OPC-262
Conditions: Diabetes, Type 2
Sponsor: Kyowa Kirin Co., Ltd.
Enrollment: 222
Primary Endpoint: Change in HBA1c form baseline
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

June 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kyowa Kirin Co., Ltd.

Responsible Party

Sponsor

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
•Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001
•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