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 END-STAGE RENAL DISEASE (ESRD) - EMPA-1

AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA0 个研究点目标入组 50 人开始时间: 2021年6月17日最近更新: 2021年8月17日

试验速览

暂无简介。

•1.Males and females
•2.Age = 30-70 years
•3.BMI< 40 Kg/m2 and stable weight (± 3 lbs) over the preceding three months
•4.Normal Glucose Tolerance (HbA1c > 4.5 % and < 5.7%) or Type 2 diabetes (HbA1c > 5.7 % and <10.0%)
•5.End Stage Renal Disease (GFR <15 ml/min/1.73 m2 or hemodialysis)
•6.Subjects are capable of giving informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1.Prednisone treatment
•2.Insulin, Beta blocker or any medication that affects sympathetic/parasympathetic activity or known to affect glucose metabolism (other than metformin and sulfonylurea)
•3.Known Empagliflozin Excipient Hypersensitivity
•4.Liver function enzymes higher more than two times the upper limit
•5.Ongoing urinary tract infection
•6.history of cancer of any type;
•7.cerebrovascular or symptomatic peripheral vascular disease;
•8.heart disease class III or IV NYHA;
•9.Type 1 Diabetes
•10.drug or alcohol abuse;
•11.life expectancy <3 yrs
•12.blood pressure >150/100 mmHg
•13.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
•14.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)
•15.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

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