NCT00997282已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 255
- 主要终点
- Changes in HbA1C from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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%
- •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 2.5 mg
Experimental
orally administered once daily for 24 weeks
干预措施: OPC-262 2.5 mg (Drug)
OPC-262 5 mg
Experimental
orally administered once daily for 24 weeks
干预措施: OPC-262 5 mg (Drug)
Placebo
Placebo Comparator
orally administered once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in HbA1C from baseline
时间窗: Week 24 (LOCF)
次要结局
- 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)
研究者
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