NCT00316758已完成2 期
A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249
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
- 259
- 主要终点
- AEs, laboratory parameters, ECG.
研究概览
简要总结
This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 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
- None
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
- •type 2 diabetic patients who have completed studies BM18248 or BM18249;
- •patients considered by the investigator to be suitable for long term treatment with GK Activator (2).
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)
1
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
AEs, laboratory parameters, ECG.
时间窗: Throughout study
次要结局
- Mean change from original baseline in HbA1c, FPG, lipid profile.(Throughout study)
研究者
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