Efficacy of Dapagliflozin Plus Metformin (drug) Versus Sitagliptin Plus Metformin (drug) for Treatment of Diabetes in Patients With liver disease.

Phase 2

• Conditions: Health Condition 1: K769- Liver disease, unspecified

• Registration Number: CTRI/2023/12/060800
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified