NCT06147518

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

An Open Label Randomized Control Trial 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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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, Dapagliflozin use leads to improvement in parameters of metabolic dysfunction, clinical decompensation and cardio-renal protection. Aim compare the safety and efficacy of metformin plus sitagliptin compared to metformin plus dapagliflozin in effective glycemic control and improvement in parameters of metabolic dysfunction, cirrhosis complications and organ dysfunction at 24 weeks. Study population:Patients with compensated and stable decompensated cirrhosis and age 18-70 years with CTP 5-8 Study design: A prospective, randomized, single center open label study The study will be conducted on the consecutive patients with liver cirrhosis and type 2 diabetes mellitus seen at the outpatient clinics of Department of Hepatology, ILBS Sample size: 200 Assuming that 40% people had HbA1c \<7 in Dapagliflozin and 25% in sitagliptin.Alpha = 5%,Power = 80%,Need to enroll total 200 cases(100 in each arm), Drop rate = 10%,Total enrollment = 100 cases (80 each arm). Randomization by block randomization method taking block size as 10 Intervention: This RCT will be conducted at ILBS New Delhi Monitoring and assessment: Monitoring will be done for all the parameters of the objective. Documentation will be done for any adverse effects which will happen. Adverse effects: to be monitored

Conditions

• Compensated Cirrhosis
• Decompensated Cirrhosis

Interventions

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

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-11-27
• Last updated: 2023-12-08

Locations

1 site across 1 country: India