NCT00857558已完成2 期
A Phase 2 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
- 2 期
- 状态
- 已完成
- 入组人数
- 350
- 主要终点
- changes in HbA1C from baseline
研究概览
简要总结
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
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 75 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 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
排除标准
- •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
研究组 & 干预措施
1
Experimental
OPC-262 1mg
干预措施: saxagliptin (Drug)
4
Placebo Comparator
干预措施: placebo (Drug)
3
Experimental
OPC-262 5mg
干预措施: saxagliptin (Drug)
2
Experimental
OPC-262 2.5mg
干预措施: saxagliptin (Drug)
结局指标
主要结局
changes in HbA1C from baseline
时间窗: 2w, 4w, 8w, 12w, 16w
次要结局
- 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)
研究者
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