A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
- Registration Number
- NCT00857558
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 placebo - 3 saxagliptin OPC-262 5mg 2 saxagliptin OPC-262 2.5mg 1 saxagliptin OPC-262 1mg
- Primary Outcome Measures
Name Time Method changes in HbA1C from baseline 2w, 4w, 8w, 12w, 16w
- Secondary Outcome Measures
Name Time Method values and changes in fasting blood glucose (FSB) from baseline 2w, 4w, 8w, 12w, 16w adverse event at any time values and changes in HbA1c form baseline 2w, 4w, 8w, 12w, 16w