A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GK1-399 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 11
- 主要终点
- Pharmacokinetic parameters of GK1-399 from plasma concentrations
研究概览
简要总结
The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be placebo, which does not contain an active ingredient. The study participation includes in-patient and out-patient days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be male or female, aged 18 through 75 years at screening.
- •Have a diagnosis of Type 2 Diabetes Mellitus (T2DM)
- •On a stable dose of background medication for the treatment of diabetes
- •Body Mass Index (BMI) between 20-40 kg/m2 (inclusive)
排除标准
- •Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease
研究组 & 干预措施
GK1-399, low dose
干预措施: GK1-399 (formerly TTP399) (Drug)
GK1-399, high dose, once per day
干预措施: GK1-399 (formerly TTP399) (Drug)
GK1-399, high dose, twice per day
干预措施: GK1-399 (formerly TTP399) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic parameters of GK1-399 from plasma concentrations
时间窗: 52 time points over a 6 week period
Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration
次要结局
- Pharmacodynamic parameters of plasma glucose(52 time points over a 6 week period)