A Randomized, Open-label Crossover Study to Investigate the Potential Interaction Between GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- AUC0-inf of GK Activator (2) and simvastatin acid.
研究概览
简要总结
This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 aged 18-75 years;
- •type 2 diabetes mellitus;
- •untreated, or taken off anti-diabetic or statin therapy >=2 weeks before study start.
排除标准
- •type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
- •diabetic neuropathy, retinopathy or nephropathy;
- •patients treated with insulin or PPAR gamma agonist within 6 weeks of screening.
研究组 & 干预措施
1
干预措施: GK Activator (2) (Drug)
2
干预措施: Simvastatin (Drug)
3
干预措施: GK Activator (2) (Drug)
3
干预措施: Simvastatin (Drug)
结局指标
主要结局
AUC0-inf of GK Activator (2) and simvastatin acid.
时间窗: Days 1, 8 and 15
AUC0-6h of plasma glucose from pre-dose to 6h post-dose.
时间窗: Days 1, 8 and 15
次要结局
- AUC0-6h of GK Activator (2) and simvastatin acid(Days 1, 8 and 15)
- AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2.(Days 1, 8 and 15)
- Cmin, tmin, Cmax, tmax, plasma glucose.(Days 1, 8 and 15)
- AEs, laboratory parameters.(Throughout study)