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

NCT06147518 | Unknown

• 1 other identifier: ILBS-Cirrhosis-68
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Compensated Cirrhosis; Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (19)

• Percentage of patients with glycemic control at 8 and 16 weeks (HBA1c <7.0 %)

  8 and 16 weeks

• Ideal body weight loss of ≥3% relative to baseline at 24 week

  24 weeks

• Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes

  8 weeks

• Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes

  16 weeks

• Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes

  24 weeks

Study Arms (2)

Metformin with Sitagliptin

ACTIVE COMPARATOR

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

Drug: Metformin; Drug: Sitagliptin

Metformin with Dapagliflozin

EXPERIMENTAL

Metformin: 1.5g/d CTPA,1g/d CTPB Dapagliflozin: Assess HbA1c/HBSG at 8 weeks, increase dapagliflozin to 10 mg if HbA1c\>7%

Drug: Metformin; Drug: Dapagliflozin

Interventions

Metformin DRUG

Metformin: 1.5g/d CTPA,1g/d CTPB

Metformin with Dapagliflozin; Metformin with Sitagliptin

Sitagliptin DRUG

Sitagliptin: Assess HbA1c/HBSG at 8 weeks, increase sitagliptin to 100 mg if HbA1c\>7%

Metformin with Sitagliptin

Dapagliflozin DRUG

Assess HbA1c/HBSG at 8 weeks, increase Dapagliflozin to 10 mg if HbA1c\>7%

Metformin with Dapagliflozin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Dr Rakesh Kumar Jagdish

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Metformin; Sitagliptin Phosphate; dapagliflozin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Central Study Contacts

Dr Jayashree Biswas, MD

CONTACT

01146300000; jayashreeb790@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 27, 2023
• Study Start: December 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

IN (1)