NCT01046318已完成3 期
A Long-term Study of OPC-262 in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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 for the entire study period and for 4 weeks after the study (end of the post-observation period)
排除标准
- •Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
- •Patients with a medical history of diabetic coma
- •Patients with poorly-controlled hypertension
- •Patients with heart failure
- •Patients with a complication of active hepatitis or hepatic cirrhosis
- •Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
- •Patients with a history or complication of malignant tumor
研究组 & 干预措施
OPC-262 5 mg
Experimental
OPC-262 5 mg will be orally administered once daily fro 52 weeks.
干预措施: OPC-262 (Drug)
结局指标
主要结局
Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)
时间窗: each visit (OC) and Week 52 (LOCF)
Clinical laboratory tests
时间窗: every 4 weeks
次要结局
- Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF)(each visit (OC) and Week 52 (LOCF))
研究者
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