Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- glycemic control through insulin, glucose, c-peptide and glucagon assays
研究概览
简要总结
This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, we will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps your pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, we hope to find out if exenatide might also be helpful in gestational diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women (singleton)
- •Gestational diabetes not requiring medical therapy
- •Between 18 and 50 years of age
- •Able to give written informed consent
排除标准
- •Women in the first trimester of pregnancy
- •Hematocrit less than 30%
- •Current or past treatment with any hypoglycemic agent
- •Women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment.
- •Women with high triglyceride levels, history of gallbladder or pancreatic disease.
- •Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)
研究组 & 干预措施
A
Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
干预措施: Exenatide (Drug)
A
Subject receives injection of 10 micrograms of Exenatide sub-cutaneously the given mixed meal test and blood samples will be drawn for laboratory testing.
干预措施: Buccal/blood Sample Collection (Genetic)
结局指标
主要结局
glycemic control through insulin, glucose, c-peptide and glucagon assays
时间窗: duing testing days
次要结局
- TCF7L2 polymorphism(During subject testing days)
- Exenatide Pharmacodynamics and Pharmacokinetics(During testing days)
研究者
Jason Umans
Prinipal Investigator
Georgetown University