Type 2 Diabetes
Conditions
Brief summary
The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in patients with type 2 diabetes by repeated administration orally for 52 weeks.
Interventions
DRUGOPC-262
OPC-262 5 mg will be orally administered once daily fro 52 weeks.
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes patients with HbA1C above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination 2. Patients who are capable of giving informed consent 3. 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
1. Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus 2. Patients with a medical history of diabetic coma 3. Patients with poorly-controlled hypertension 4. Patients with heart failure 5. Patients with a complication of active hepatitis or hepatic cirrhosis 6. Patients undergoing treatment of glomerular diseases other than diabetic nephropathy 7. Patients with a history or complication of malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF) | each visit (OC) and Week 52 (LOCF) |
| Clinical laboratory tests | every 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF) | each visit (OC) and Week 52 (LOCF) |
Countries
Japan
Outcome results
None listed