Diabetes, Type 2
Conditions
Brief summary
A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes
Interventions
DRUGsaxagliptin
orally administration at 1 mg once a day for 12 weeks
DRUGplacebo
orally administration once a day for 12 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 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes patients with HbA1c above 7.0% and below 10% * 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 type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus * Patients with a medical history of diabetes coma * Patients with poorly-controlled hypertension * Patients with heart failure * Patients with a complication of active hepatitis or hepatic cirrhosis * Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy * Patients with a history or complication of malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in HbA1C from baseline | 2w, 4w, 8w, 12w, 16w |
Secondary
| Measure | Time frame |
|---|---|
| values and changes in HbA1c form baseline | 2w, 4w, 8w, 12w, 16w |
| values and changes in fasting blood glucose (FSB) from baseline | 2w, 4w, 8w, 12w, 16w |
| adverse event | at any time |
Countries
Japan
Outcome results
None listed