NCT01634282CompletedPhase 3
A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 222
- Primary Endpoint
- Change in HBA1c form baseline
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
OPC-262
Experimental
Intervention: OPC-262 (Drug)
Outcomes
Primary Outcomes
Change in HBA1c form baseline
Time Frame: 52 Weeks
Incidence and severity of adverse events
Time Frame: 52 Weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
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