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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

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