The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Insulin secretion
研究概览
简要总结
The major cause of premature death in renal transplant recipients is cardiovascular disease. Sitagliptin stimulates insulin secretion and inhibits glucagon release, two central mechanisms in PTDM by interaction with a hormone system (incretins) that just recently it has become possible to modulate by drugs. Sitagliptin therefore is an interesting additional drug for the treatment of posttransplant diabetes mellitus in transplanted patients.
The primary objective of the present study is to investigate the effect of sitagliptin on insulin secretion in renal transplant recipients.
Secondary objectives are to study the effect on insulin sensitivity, fasting blood glucose, endothelial function, CsA/Tac blood concentrations.
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
- None
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
- •Renal transplant recipient more than 1 year posttransplant with stable renal function (less than 20% deviation in serum creatinine the last 2 months) and stable prednisolone dose for the last 3 months before inclusion.
- •Patients in need of (additional) oral anti-diabetic treatment:
- •New onset diabetes patients with fasting plasma glucose 7-8 mmol/ l, and/or 2-hr plasma glucose 12-18 mmol/l after an oral glucose tolerance test (OGTT)
- •Patients already on oral hypoglycemic therapy, but with HbA1c 8-11%
- •18 years of age.
- •Male patient, or female patient without childbearing potential (surgically sterilized or postmenopausal) or, if female of childbearing potential, is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 Days following discontinuation of the Study Drugs.
- •Signed informed consent.
排除标准
- •Treatment with insulin
- •Severe liver disease.
- •Estimated GFR < 25 ml/min/1.73 m
- •Skin disorders that may influence laser Doppler flowmetry investigations.
- •Pregnant or nursing mothers.
研究组 & 干预措施
A
Patients will receive 4 weeks of treatment with sitagliptin once daily
干预措施: sitagliptin (Drug)
B
No treatment for 4 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Insulin secretion
时间窗: 4 weeks
次要结局
- Insulin sensitivity(4 weeks)
- Fasting blood glucose(4 weeks)
- Endothelial function(4 weeks)
- Cyclosporine/tacrolimus blood concentrations(4 weeks)