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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Nov 23, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how well two different diabetes medications, Dapagliflozin plus Metformin and Sitagliptin plus Metformin, work for people who have diabetes and liver cirrhosis. The goal is to see which combination is safer and more effective in lowering blood sugar levels, while also checking for other benefits like weight loss and improvements in cholesterol levels. The trial is designed for adults aged 18 to 70 who have stable liver cirrhosis and type 2 diabetes but haven't taken certain diabetes medications recently.

To participate, individuals must have a specific blood sugar level and a body mass index (BMI) that meets certain criteria. Participants can expect to be closely monitored throughout the study to ensure they are taking their medications correctly. It's important to note that certain health conditions, like severe kidney problems or recent heart issues, may prevent someone from joining the trial. This study will last for one year after receiving the necessary ethical approvals, and the aim is to help find better treatment options for diabetes in patients with liver cirrhosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.