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

Kyowa Kirin

Status and phase

Completed

Phase 3

Conditions

Diabetes, Type 2

Treatments

Drug: OPC-262

Study type

Interventional

Funder types

Industry

Identifiers

NCT01634282

262-09-002

Details and patient eligibility

About

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

Enrollment

222 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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