A Phase II, Four-week, Multi-center, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Safety and Efficacy of EGT0001442 in Subjects With Type 2 Diabetes Mellitus With an Ascending Dose Safety and Pharmacokinetic Evaluation Period
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 12
- 主要终点
- Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study
研究概览
简要总结
The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.
The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.
详细描述
This was a phase 2 study to evaluate the efficacy of
EGT0001442. The study included two segments:
Segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.
Segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.
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 female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
- •Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
- •HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
- •Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
- •Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).
- •If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
- •Female subjects must be surgically sterilized or postmenopausal.
排除标准
- •Type 1 diabetes or diabetes treated with insulin injection.
- •Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
- •Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
- •Positive results on screen for drugs of abuse.
- •Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
- •Previous treatment with EGT0001474 or EGT0001442.
研究组 & 干预措施
EGT0001442
干预措施: EGT0001442 (Drug)
Placebo
干预措施: Placebo capsules to match EGT0001442 (Drug)
结局指标
主要结局
Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study
时间窗: Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29
Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.
Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4
时间窗: Pre-dose to 48 h post-dose
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4
时间窗: Pre-dose to 48 h post-dose
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
次要结局
- Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28(Baseline, Day 1 and Day 28)
- Change in FPG Following Cessation of Treatment(Days 27/29 to Days 41/43)
- Change in the Body Weight From Baseline at Week 4(Baseline and Day 29)
- Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4(Baseline and Day 29)