UnknownNot Applicable

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

India240 participantsStarted 2023-12-20

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Age 18-70 years
✓. Child A/B Liver cirrhosis in outpatient setting
✓. 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
✓. HbA1c level of 7.1% or higher but no more than 9.0%
✓. BMI of 23 kg/m2 or higher
✓. patients who can be monitored closely for medication compliance
✓. patients who provide written informed consent.

Exclusion criteria

✕. Age \<18 years
✕. Post renal or liver transplantation
✕. CTP C / ACLF
✕. Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection
✕. Active sepsis / SBP at enrollment
✕. Grade II/III/IV HE
✕. Pregnancy or Lactating mother
✕. Known CKD, obstructive uropathy

What they're measuring

Percentage of patients with glycemic control at 24 weeks (HBA1c <7.0 %)

Timeframe: 24 weeks

Trial details

NCT IDNCT06147518

SponsorInstitute of Liver and Biliary Sciences, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Dr Jayashree Biswas, MD

01146300000 jayashreeb790@gmail.com

View on ClinicalTrials.gov More Compensated Cirrhosis trials