A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]
研究概览
简要总结
This study is a Phase 2, randomized, double-blind, placebo-controlled, single-center study in adult patients with type 2 diabetes. It will evaluate the safety and tolerability of oral GLY-200. Subjects will participate in a ≤ 18-day screening period followed by a metformin washout period of approximately 14 days, and an inpatient period of 16 days. Approximately 48 subjects will be randomized to 1 of 3 active treatment groups or 1 of 3 placebo groups. Dosing will occur for 14 days. A follow-up clinic visit will occur on Day 21 [End of Study (EOS)] or Early Termination (ET).
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 2 diabetes: hemoglobin A1c (HbA1c)) ≥ 6.0 and ≤ 8.5% at screening
- •Body mass index (BMI) ≥ 18 and ≤ 40 at screening
排除标准
- •Treated with any prescription medication for the treatment of type 2 diabetes or weight loss other than metformin in the last 3 months prior to screening
- •Use of any drug treatment that affects gastric pH
- •Use of any drug treatment that affects gastrointestinal motility
- •Fasting blood glucose > 190 mg/dL
- •Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract or active disease within 12 months prior to screening
- •History of any previous abdominal or intestinal surgery including endoscopic, open or laparoscopic thoracic or abdominal surgery, surgical resection of the stomach, small or large intestine
- •Clinically significant medical condition as judged by the Investigator that could potentially affect study participation and/or personal well-being
研究组 & 干预措施
0.5 g GLY-200
0.5 g GLY-200 (1 x 0.5 g capsule) twice a day (BID)
干预措施: GLY-200 (Drug)
1.0 g GLY-200
1.0 g GLY-200 (2 x 0.5 g capsule) twice a day (BID)
干预措施: GLY-200 (Drug)
2.0 g GLY-200
2.0 g GLY-200 (4 x 0.5 g capsule) twice a day (BID)
干预措施: GLY-200 (Drug)
Placebo for 0.5 g GLY-200 arm
1 placebo capsule twice a day (BID)
干预措施: Placebo (Drug)
Placebo for 1.0 g GLY-200 arm
2 placebo capsules twice a day (BID)
干预措施: Placebo (Drug)
Placebo for 2.0 GLY-200 arm
4 placebo capsules twice a day (BID)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]
时间窗: Over the 14-day treatment period
Safety and tolerability will be assessed by incidence of adverse events (AEs). Clinically significant changes from baseline in vital signs, clinical laboratory parameters, and electrocardiograms (ECGs) will be recorded as AEs.
次要结局
- Change From Baseline in Fasting Glucose(Day 1, Day 7, and Day 14)
- Change From Baseline in 3-hours Postprandial Plasma Insulin Profile(Day 1, Day 7, and Day 14)
- Change From Baseline in Fasting Plasma Insulin(Day 1, Day 7, and Day 14)
- Change From Baseline in 3-hours Postprandial Plasma Glucose Profile(Day 1, Day 7, and Day 14)