Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-16
Brief Title:
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
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 populationPatients 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 sitagliptinAlpha 5Power 80Need to enroll total 200 cases100 in each arm Drop rate 10Total 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
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 populationPatients 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 sitagliptinAlpha 5Power 80Need to enroll total 200 cases100 in each arm Drop rate 10Total 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None