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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes prevalence is increasing among cirrhotics and use of OAD in cirrhotics is limited because of risk of hypoglycaemia and other adverse effects, therefore in this study we would be using OAD in the form of Sitagliptin or Dapagliflozin to look for glycemic response as well as to look for other benefits such as weight reduction and improvement in lipid parameters.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Dapagliflozin; Metformin; Sitagliptin Phosphate

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.