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

Sponsor
Institute of Liver and Biliary Sciences, India
Study ID
NCT06147518
Status
Unknown

Conditions

  • Compensated Cirrhosis
  • Decompensated Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Metformin: 1.5g/d CTPA,1g/d CTPB
  • Sitagliptin — DRUG
    Sitagliptin: Assess HbA1c/HBSG at 8 weeks, increase sitagliptin to 100 mg if HbA1c\>7%
  • Dapagliflozin — DRUG
    Assess HbA1c/HBSG at 8 weeks, increase Dapagliflozin to 10 mg if HbA1c\>7%

Study Details

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.

Key Dates

Start date
Dec 20, 2023
Status verified
Nov 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin with Sitagliptin
    Metformin: 1.5g/d CTPA,1g/d CTPB Sitagliptin: Assess HbA1c/HBSG at 8 weeks, increase sitagliptin to 100 mg if HbA1c\>7%
  • Experimental: Metformin with Dapagliflozin
    Metformin: 1.5g/d CTPA,1g/d CTPB Dapagliflozin: Assess HbA1c/HBSG at 8 weeks, increase dapagliflozin to 10 mg if HbA1c\>7%

Primary Outcome Measure

Percentage of patients with glycemic control at 24 weeks (HBA1c <7.0 %) [ Time Frame: 24 weeks ]

Central Contacts

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