A Phase II,Randomized,Cross-over,Double-blind, Placebo- Controlled,Single Center Study of the Effect of Empagliflozin a SGLT-2 Inhibitor,on Endogenous Glucose Production and Plasma Glucagon Levels in Patients With ESRD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes in plasma Glucose level
研究概览
简要总结
A study of the effects of empagliflozin, a SGLT-2 inhibitor, on endogenous glucose production and plasma glucagon levels in patients with end-stage renal disease (ESRD)
详细描述
The impact of SGLT-2 inhibition on endogenous glucose production and plasma glucagon levels will be compared measured in patients with ESRD.The secondary endpoints are the mean difference in plasma glucose, insulin, c-peptide, FFA,GH, epinephrine, norepinephrine, cortisol and blood pressure during the last hour of the experiment between empagliflozin versus placebo administration in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Males and females
- •Age = 30-70 years
- •BMI< 40 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
- •Normal Glucose Tolerance (HbA1c > 4.5 % and < 5.7%) or Type 2 diabetes (HbA1c >5.7 % and <10.0%)
- •End Stage Renal Disease (GFR <15 ml/min/1.73 m 2 or hemodialysis)
- •Subjects are capable of giving informed consent
排除标准
- •Prednisone treatment
- •Beta blocker or any medication that affects sympathetic/parasympathetic activity
- •Known Empagliflozin Excipient Hypersensitivity
- •Liver function enzymes higher more than two times the upper limit
- •Ongoing urinary tract infection
- •history of cancer of any type;
- •cerebrovascular or symptomatic peripheral vascular disease;
- •heart disease class III or IV NYHA;
- •Type 1 Diabetes
- •drug or alcohol abuse;
- •life expectancy <3 yrs
- •blood pressure >150/100 mmHg
- •Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter
- •Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment)
- •Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures
研究组 & 干预措施
Empagliflozin
SGLT-2 inhibitor
干预措施: Empagliflozin (Combination Product)
placebo
A substance without specific pharmacology principles.
干预措施: Empagliflozin (Combination Product)
placebo
A substance without specific pharmacology principles.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in plasma Glucose level
时间窗: 2 hours
Because of their mechanism of action, SGLT-2 inhibitor efficacy to reduce plasma glucose level is highly dependent upon renal function. With GFR decreasing, glucose tubular load will decrease and less glucose will be reabsorbed because of SGLT2-inhibition.
次要结局
未报告次要终点
研究者
Prof. Stefano Del Prato
Clinical Resercher
University of Pisa