type 2 diabetes
Conditions
Interventions
investigational material(s)
Generic name etc : OPC-262 2.5 mg
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational mater
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 |
|---|---|
| HbA1c change from baseline at Week 24 (LOCF) | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting blood glucose (FBG) change from baseline at Week 24 (LOCF) 2 hour postprandial blood glucose (PPG) change from baseline at Week 24 (LOCF) 3 hour PPG AUC change from baseline at Week 24 (LOCF) | — |
Outcome results
None listed