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 Treated With a Stable Dose of Metformin.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- HbA1c mean change from baseline compared with placebo.
研究概览
简要总结
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. 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;
- •individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.
排除标准
- •type 1 diabetes mellitus;
- •any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
研究组 & 干预措施
1
干预措施: GK Activator (2) (Drug)
1
干预措施: Metformin (Drug)
2
干预措施: GK Activator (2) (Drug)
2
干预措施: Metformin (Drug)
3
干预措施: GK Activator (2) (Drug)
3
干预措施: Metformin (Drug)
4
干预措施: GK Activator (2) (Drug)
4
干预措施: Metformin (Drug)
5
干预措施: GK Activator (2) (Drug)
5
干预措施: Metformin (Drug)
6
干预措施: Metformin (Drug)
结局指标
主要结局
HbA1c mean change from baseline compared with placebo.
时间窗: Week 12
次要结局
- AEs, laboratory parameters.(Throughout study)
- Additional parameters of glycemic and lipid control.(Week 12)
- Pharmacokinetic and exposure-response relationship(Throughout study)