An open-label randomized control trial to Compare the Safety and Efficacy of Dapagliflozin Plus Metformin Versus Sitagliptin Plus Metformin for Treatment of Diabetes in Patients With Compensated and Stable Decompensated Cirrhosis. - NI

Institute of Liver and Biliary Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1.Age 18-70 years
•2.Child A/B Liver cirrhosis in outpatient setting
•3.T2DM patients who have not used any glucose-lowering agents within 8 weeks before consenting, or those who have only used metformin, in addition to diet and exercise
•4.HbA1c level of 7.1% or higher but no more than 9.0%
•5.BMI of 23 kg/m2 or higher
•6.patients who can be monitored closely for medication compliance
•7.patients who provide written informed consent.

•1.Age <18 years
•2.Post renal or liver transplantation
•3.CTP C / ACLF
•4.Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection
•5.Active sepsis / SBP at enrollment
•6.Grade II/III/IV HE
•7.Pregnancy or Lactating mother
•8.Known CKD, obstructive uropathy
•9.Patient on MV, NIV, systemic sepsis and shock
•10.Lack of informed consent
•11.Prior intolerance or S/E to SGLT-2i or DPP4i
•12.patients with type 1 diabetes or secondary diabetes
•13.patients with medical history of diabetic ketoacidosis
•14.patients with medical history of myocardial infarction, cerebral infarction, or stroke within 12 weeks before consent to the study
•15.estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2
•16.unstable hypertension or dyslipidemia within 12 weeks before consent to the study
•17.HB <9 g/L, patients with haemoglobinopathy, acute hemolysisStudy period: one year after ethical approval.

发起方