Compensated CirrhosisNCT06147518
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
A study testing Metformin, Sitagliptin and Dapagliflozin in people with Compensated Cirrhosis and Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Compensated Cirrhosis, Decompensated Cirrhosis
- What is being tested?
- Metformin, Sitagliptin and Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIndia
- Study dates
- 20 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- unstable hypertension or dyslipidemia within 12 weeks before consent to the study
- HB <9 g/L, patients with haemoglobinopathy, acute hemolysisStudy period: one year after ethical approval.
Trial locations and contacts
1 site in 1 country.
India1 site
Dr Rakesh Kumar Jagdish
New Delhi, National Capital Territory of Delhi, 110070
Dr Jayashree Biswas, MD, 01146300000, jayashreeb790@gmail.com
About this study
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
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.
Read the 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
- Being tested
- Metformin, Sitagliptin, Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin: 1.5g/d CTPA,1g/d CTPB
SitagliptinDrug
Sitagliptin: Assess HbA1c/HBSG at 8 weeks, increase sitagliptin to 100 mg if HbA1c>7%
DapagliflozinDrug
Assess HbA1c/HBSG at 8 weeks, increase Dapagliflozin to 10 mg if HbA1c>7%
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: 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% Receives: Drug: Metformin; Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with glycemic control at 24 weeks (HBA1c <7.0 %)
Measured: 24 weeks
Secondary outcomes (19)
Percentage of patients with glycemic control at 8 and 16 weeks (HBA1c <7.0 %)
Measured: 8 and 16 weeks
Ideal body weight loss of ≥3% relative to baseline at 24 week
Measured: 24 weeks
Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes
Measured: 8 weeks
Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes
Measured: 16 weeks
Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes
Measured: 24 weeks
Changes in HbA1c at 24 week relative to baseline
Measured: 24 weeks
Changes in BMI at 24 week relative to baseline
Measured: 24 weeks
changes in Blood insulin at 24 week
Measured: 24 weeks
changes in lipid profile at 24 week
Measured: 24 weeks
Change in ALT at 8, 16 and 24 week
Measured: 8, 16 and 24 week
Change in HVPG at 24 week compared to baseline
Measured: 24 weeks
Change in LSM at 24 week compared to baseline
Measured: 24 weeks
Change in SSM at 24 week compared to baseline
Measured: 24 weeks
Incidence of urinary protein excretion at 8, 16 and 24 weeks
Measured: 8, 16 and 24 weeks
Incidence of serum creatinine at 8, 16 and 24 weeks
Measured: 8, 16 and 24 weeks
Number of patients with Complications of cirrhosis (ascites, HE, Bleed, AKI, Infection) at 24 week
Measured: 24 weeks
Medicine adherence rate in both groups
Measured: 24 weeks
Adverse effects to study drugs in both groups
Measured: 24 weeks
Number of patients with Mortality/ Liver transplantation in both groups
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start20 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compensated CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147518
- Sponsor's protocol ID
- ILBS-Cirrhosis-68
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06147518
- Acronym / sponsor ID
- ILBS-Cirrhosis-68
- Conditions
- Compensated Cirrhosis, Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin with Sitagliptin | Active comparator | Drug: Metformin, Drug: SitagliptinMetformin: 1.5g/d CTPA,1g/d CTPB Sitagliptin: Assess HbA1c/HBSG at 8 weeks, increase sitagliptin to 100 mg if HbA1c>7% |
| Metformin with Dapagliflozin | Experimental | Drug: Metformin, Drug: DapagliflozinMetformin: 1.5g/d CTPA,1g/d CTPB Dapagliflozin: Assess HbA1c/HBSG at 8 weeks, increase dapagliflozin to 10 mg if HbA1c>7% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin: 1.5g/d CTPA,1g/d CTPB | Drug | Metformin with Dapagliflozin, Metformin with Sitagliptin |
| SitagliptinSitagliptin: Assess HbA1c/HBSG at 8 weeks, increase sitagliptin to 100 mg if HbA1c>7% | Drug | Metformin with Sitagliptin |
| DapagliflozinAssess HbA1c/HBSG at 8 weeks, increase Dapagliflozin to 10 mg if HbA1c>7% | Drug | Metformin with Dapagliflozin |
Primary outcome
Percentage of patients with glycemic control at 24 weeks (HBA1c <7.0 %)
Time frame: 24 weeks
19 secondary outcomes
Percentage of patients with glycemic control at 8 and 16 weeks (HBA1c <7.0 %)
Time frame: 8 and 16 weeks
Ideal body weight loss of ≥3% relative to baseline at 24 week
Time frame: 24 weeks
Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes
Time frame: 8 weeks
Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes
Time frame: 16 weeks
Incidence and frequency of hypoglycemia (BS <54 mg/dl) episodes
Time frame: 24 weeks
Changes in HbA1c at 24 week relative to baseline
Time frame: 24 weeks
Changes in BMI at 24 week relative to baseline
Time frame: 24 weeks
changes in Blood insulin at 24 week
Time frame: 24 weeks
changes in lipid profile at 24 week
Time frame: 24 weeks
Change in ALT at 8, 16 and 24 week
Time frame: 8, 16 and 24 week
Change in HVPG at 24 week compared to baseline
Time frame: 24 weeks
Change in LSM at 24 week compared to baseline
Time frame: 24 weeks
Change in SSM at 24 week compared to baseline
Time frame: 24 weeks
Incidence of urinary protein excretion at 8, 16 and 24 weeks
Time frame: 8, 16 and 24 weeks
Incidence of serum creatinine at 8, 16 and 24 weeks
Time frame: 8, 16 and 24 weeks
Number of patients with Complications of cirrhosis (ascites, HE, Bleed, AKI, Infection) at 24 week
Time frame: 24 weeks
Medicine adherence rate in both groups
Time frame: 24 weeks
Adverse effects to study drugs in both groups
Time frame: 24 weeks
Number of patients with Mortality/ Liver transplantation in both groups
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin, Sitagliptin and Dapagliflozin in people with Compensated Cirrhosis and Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Jayashree Biswas, MD (01146300000, jayashreeb790@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with glycemic control at 24 weeks (HBA1c <7.0 %) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.