An Open-label, Crossover Study to Investigate the Potential Pharmacodynamic and Potential Pharmacokinetic Interaction Between Glyburide and GK Activator(2) in Type 2 Diabetes Patients Inadequately Controlled With Glyburide as Standard Prescribed Therapy.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- AUC0-6h of plasma glucose
研究概览
简要总结
This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. 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
- Non 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; currently on glyburide 10-20 mg/day for >=3 months;
- •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 with 6 weeks of screening.
研究组 & 干预措施
1
干预措施: GK Activator (2) (Drug)
1
干预措施: Glyburide (Drug)
2
干预措施: GK Activator (2) (Drug)
3
干预措施: Glyburide (Drug)
结局指标
主要结局
AUC0-6h of plasma glucose
时间窗: Days -1, 6 and 12
AUC0-12h of GK Activator (2) and metabolite.
时间窗: Days 6 and 12
AUC0-tau of glyburide
时间窗: Days -1 and 6
次要结局
- AEs, laboratory parameters.(Throughout study)