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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

NCT ID: NCT06147518

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Compensated Cirrhosis Decompensated Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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%

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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

Sitagliptin

Intervention Type DRUG

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

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%

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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

Dapagliflozin

Intervention Type DRUG

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

Interventions

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Metformin

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

Intervention Type DRUG

Sitagliptin

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

Intervention Type DRUG

Dapagliflozin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr Rakesh Kumar Jagdish

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Central Contacts

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Dr Jayashree Biswas, MD

Role: CONTACT

Phone: 01146300000

Email: [email protected]

Facility Contacts

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Dr Jayashree Biswas, MD

Role: primary

Other Identifiers

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ILBS-Cirrhosis-68

Identifier Type: -

Identifier Source: org_study_id