Diabetes Type 2
Conditions
Brief summary
The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.
Interventions
DRUGOPC-262 2.5 mg
orally administered once daily for 24 weeks
DRUGOPC-262 5 mg
orally administered once daily for 24 weeks
DRUGPlacebo
orally administered once daily for 24 weeks
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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% 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 | Week 24 (LOCF) |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fasting blood glucose (FBG) from baseline | Week 24 |
| Changes in 2 hour postprandial blood glucose (PPG) from baseline | Week 24 |
| Changes in 3 hour PPG AUC from baseline | Week 24 |
Countries
Japan
Outcome results
None listed