A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of EGT0001474 in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC 0-t
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how much of the drug gets into the blood and how long it takes the body to get rid of it) of single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.
详细描述
EGT0001474 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001474 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. This would help prevent an abnormal decrease in blood sugar (hypoglycemia) both during fasting and after meals without increasing insulin secretion (which may result in weight gain or an abnormal increase in blood sugar known as Type 2 diabetes).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females between the ages of 18 to 70 diagnosed with Type 2 diabetes.
- •Body mass Index (BMI) between 18 kg/m2 and 37 kg/m
- •HbA1c levels between 6.5 and 9.0 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or 6.2-9.0% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1% and fasting plasma glucose between 110 and 240 mg/dL (inclusive) while on diabetic medications.
- •If taking drugs for diabetes, must be medically able and willing to discontinue diabetes medications for the duration of the study.
- •Female subjects must be surgically sterilized or postmenopausal.
- •Non-smoker for at least 3 months.
- •Negative alcohol screen.
排除标准
- •Type 1 diabetes.
- •Use of insulin therapy or oral antidiabetic medication other than metformin, sitagliptin or a sulfonylurea.
- •Sitting blood pressure above 150/95 mmHg on 2 evaluations at least 10 minutes apart at screening.
- •Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
- •Previous treatment with EGT
- •Vaccination within 30 days prior to the first dose of study medication.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
EGT0001474
干预措施: EGT0001474 (Drug)
结局指标
主要结局
AUC 0-t
时间窗: 3 days
Area under the plasma concentration-time curve from time 0 to time t
Safety and Tolerability of EGT0001474
时间窗: 25 days
Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.
AUC0-24
时间窗: 3 days
Area under the plasma concentration-time curve from time 0 to hour 24
AUC Inf
时间窗: 3 days
Area under the plasma concentration-time curve from time 0 to infinity
Cmax
时间窗: 3 days
Maximum plasma concentration
Tmax
时间窗: 3 days
Time of maximum plasma concentration
λz
时间窗: 3 days
Terminal phase rate constant
t1/2
时间窗: 3 days
Apparent terminal half life
CL/F
时间窗: 3 days
The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.
Vz/F
时间窗: 3 days
Apparent volume of distribution
次要结局
未报告次要终点