Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Metformin with Dapagliflozin: Dapagliflozin: Assess HbA1c/HBSG at 8 weeks, increase dapagliflozin to 10 mg if HbA1c7%.
Duration: 24 weeks.
Control Intervention1: Metformin with Sitaglip
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion 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
Exclusion criteria: 1. Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with glycemic control at 24 weeks (HBA1c Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects to study drugsTimepoint: 24 weeks;Change in ALT at 8, 16 and 24 weekTimepoint: 8, 16 and 24 weeks;Change in HVPG, LSM, SSM at 24 week compared to baselineTimepoint: 24 weeks;Changes in HbA1c and BMI at 24 week relative to baselineTimepoint: 24 weeks;Changes in lipid profile, Blood insulin at 24 weekTimepoint: 24 weeks;Complications of cirrhosis (ascites, HE, Bleed, AKI, Infection) at 24 weekTimepoint: 24 weeks;Ideal body weight loss of =3% relative to baseline at 24 weekTimepoint: 24 weeks;Incidence and frequency of hypoglycemia (BS Timepoint: 24 week;Mortality/ Liver transplantation at 24 weekTimepoint: 24 weeks;Percentage of patients with glycemic control at 8 and 16 weeks (HBA1c <7.0 %)Timepoint: 8 & 16 weeks | — |
Countries
India
Contacts
Public ContactDr Ankur Jindal
Institute of Liver and Biliary Sciences
Outcome results
None listed