NCT00266240已完成2 期
A Randomized, Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus
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
- 267
- 主要终点
- HbA1c mean change from baseline, compared to placebo.
研究概览
简要总结
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients 30-75 years of age;
- •type 2 diabetes mellitus for >3 months before screening;
- •treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).
排除标准
- •type 1 diabetes mellitus;
- •women who are pregnant, breast-feeding or not using adequate contraceptive methods.
研究组 & 干预措施
1
Experimental
干预措施: GK Activator (2) (Drug)
2
Experimental
干预措施: GK Activator (2) (Drug)
3
Experimental
干预措施: GK Activator (2) (Drug)
4
Experimental
干预措施: GK Activator (2) (Drug)
5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c mean change from baseline, compared to placebo.
时间窗: Week 12
次要结局
- Additional parameters of glycemic and lipid control.(Week 12)
- AEs, laboratory parameters.(Throughout study)
- Pharmacokinetic and exposure-response relationship(Throughout study)
研究者
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