The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Insulin release
研究概览
简要总结
The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.
详细描述
To date, no clinical trials have been conducted using the DPPIV inhibitor sitagliptin in cystic fibrosis-related diabetes. Cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. As the disease progresses, fasting hyperglycemia develops. As sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older
- •Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy
排除标准
- •Age under 19 years
- •Use of basal insulin therapy
- •Creatinine Clearance < 50 mL/min
- •Active cystic fibrosis exacerbation
- •Pregnancy
- •Women of child-bearing age not using effective contraception
- •Current or prior use of DPPIV inhibitor
研究组 & 干预措施
Sitagliptin
干预措施: Sitagliptin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Insulin release
时间窗: 180 minutes (during clamp)
The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.
次要结局
- Incretin Response(180 minutes (during clamp))