A Double-Blind, Randomized, Placebo Controlled Intervention Study to Assess the Impact of Sitagliptin 100 mg/Day for 1 Year on Insulin Independence Following Pancreatectomy and Autoislet Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Insulin Independence
研究概览
简要总结
The purpose of the study is to test the effects of sitagliptin on the need for insulin (the hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet autotransplant for chronic pancreatitis.
详细描述
At the current time, about one-third of patients are insulin independent (do not need to take insulin) after autotransplant, but the other two-thirds still need some insulin. Sitagliptin works by increasing the amount of a hormone called glucagon-like peptide 1, or GLP-1, in the body which then increases the amount of insulin that is made by the beta cells(the insulin producing cell of the islets). GLP-1 might also help protect beta cells from dying under stressful conditions and increase the production of new beta cells.
The primary goal of this study is to see if taking sitagliptin for one year after islet autotransplant increases the number of patients who achieve and maintain insulin independence. Other goals of this study are to see if sitagliptin reduces the amount of insulin injections needed or helps the islets make more insulin.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Scheduled for total pancreatectomy and IAT at UM
排除标准
- •Pre-existing diabetes mellitus or hyperglycemia with fasting glucose ≥115 mg/dl
- •Medical conditions which, in the opinion of the investigator, might impact islet function (e.g asthma or inflammatory disease requiring chronic systemic corticosteroids)
- •Significant renal disease: serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women, or end-stage renal disease requiring hemodialysis or peritoneal dialysis.
- •For female subjects, plans to become pregnant or unwillingness to practice birth control for 18 months.
- •Islet yield <1,000 IE/kg body weight (exclusion for treatment with drug/placebo)
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 Independence
时间窗: 12 months
percentage of patients insulin independent
次要结局
- Area Under the Curve (AUC) C-peptide (ng/dL*Min)(12 months)
- AUC C-peptide(18 months)
- Insulin Independence(18 months)
- Acute C-peptide Response (ACR) to Glucose(18 months)