A long-term clinical study of OPC-262 in patients with type 2 diabetes
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-jRCT2080221847
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 175
(1) Patients who completed Study 262-09-001 (patients who visited the hospital at visit Week 24)
(2) Patients who are capable of giving informed consent prior to participating in this clinical study
(3) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner
(1) Patients who withdrew fyom Study 262-09-001
(2) Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001
(3) 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
(4) Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001
(5) Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study
(6) Patients other wise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: HbA1c<br>Safety: Adverse events<br>Efficacy: Changes from baseline<br>Safety: Incidence and Severity
- Secondary Outcome Measures
Name Time Method