An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- Percentage of patients at each dose who achieve FPG <100mg/dL.
研究概览
简要总结
This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.
排除标准
- •type 1 diabetes mellitus;
- •treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
- •women who are pregnant, breast-feeding or not using adequate contraceptive methods.
研究组 & 干预措施
5
干预措施: GK Activator (2) (Drug)
1
干预措施: GK Activator (2) (Drug)
2
干预措施: GK Activator (2) (Drug)
3
干预措施: GK Activator (2) (Drug)
4
干预措施: GK Activator (2) (Drug)
结局指标
主要结局
Percentage of patients at each dose who achieve FPG <100mg/dL.
时间窗: Throughout study
次要结局
- AEs, laboratory parameters.(Throughout study)
- Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.(At intervals throughout study)