Diabetes, Type 2
Conditions
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
Interventions
DRUGOPC-262
Orally administered once daily
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HBA1c form baseline | 52 Weeks |
| Incidence and severity of adverse events | 52 Weeks |
Countries
Japan
Outcome results
None listed