Along-term Study of OPC-262 in Patients With Type 2 Diabetes
- Registration Number
- NCT01634282
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OPC-262 OPC-262 -
- Primary Outcome Measures
Name Time Method Change in HBA1c form baseline 52 Weeks Incidence and severity of adverse events 52 Weeks
- Secondary Outcome Measures
Name Time Method