NCT01193179
Completed
Phase 3
Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus
Overview
- Phase
- Phase 3
- Intervention
- OPC-262
- Conditions
- Diabetes, Type 2
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 450
- Primary Endpoint
- Adverse events, clinical laboratory tests
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who are capable of giving informed consent
- •Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner
Exclusion Criteria
- •Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
Arms & Interventions
OPC-262
Intervention: OPC-262
Outcomes
Primary Outcomes
Adverse events, clinical laboratory tests
Time Frame: 52 weeks
Secondary Outcomes
- Secondary Outcome HbA1c(52 weeks)
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