Status:
UNKNOWN
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
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Compensated Cirrhosis
Decompensated Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Detailed Description
Hypothesis In patients with cirrhosis and T2DM with poor glycemic control on metformin requiring dual therapy, Dapagliflozin is safe and superior to Sitagliptin in achieving glycemic control. Moreover...
Eligibility Criteria
Inclusion
- 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
- 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
- Patient on MV, NIV, systemic sepsis and shock
- Lack of informed consent
- Prior intolerance or S/E to SGLT-2i or DPP4i
- patients with type 1 diabetes or secondary diabetes
- patients with medical history of diabetic ketoacidosis
- patients with medical history of myocardial infarction, cerebral infarction, or stroke within 12 weeks before consent to the study
- estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2
- unstable hypertension or dyslipidemia within 12 weeks before consent to the study
- HB \<9 g/L, patients with haemoglobinopathy, acute hemolysisStudy period: one year after ethical approval.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06147518
Start Date
December 20 2023
End Date
December 31 2024
Last Update
December 8 2023
Active Locations (1)
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1
Dr Rakesh Kumar Jagdish
New Delhi, National Capital Territory of Delhi, India, 110070