A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-ascending-dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of R1511 in Type 2 Diabetic (T2D) Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- AEs, laboratory parameters, vital signs.
研究概览
简要总结
This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-65 years of age;
- •type 2 diabetic patients;
- •naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment.
排除标准
- •type 1 diabetes mellitus;
- •clinically significant cardiovascular disease.
研究组 & 干预措施
1
干预措施: RG1511 (Drug)
2
干预措施: RG1511 (Drug)
3
干预措施: RG1511 (Drug)
4
干预措施: Placebo (Drug)
结局指标
主要结局
AEs, laboratory parameters, vital signs.
时间窗: Throughout study
Glucose AUC
时间窗: Days -1, 1 and 8.
次要结局
- Pharmacokinetic parameters(Days 1 and 8)
- Insulin, C-peptide, glucagon and GLP-1 AUC(Days -1, 1 and 8)
- 24h glucose(Days -1, 1 and 8)
- Lipid profiles(Days -1 and 8)