Type 2 Diabetes MellitusEMPA-LIVERNCT07915596
Effect of Empagliflozin on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
An observational study of Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
This prospective, open-label, randomized clinical study will evaluate the effect of empagliflozin 10 mg daily, added to standard T2DM treatment, on liver fat and hepatic parameters in adults with type 2 diabetes and nonalcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Nonalcoholic Fatty Liver Disease
- What is being tested?
- Empagliflozin 10/15 mg administered orally once daily in addition to standard treatment for type 2 diabetes mellitus.
- Type of treatment
- Pill or oral medicine
- How many people
- 792 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2023to 31 Dec 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will comprise adults aged 18 years or older with type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) who meet the predefined eligibility criteria. Eligible participants will have an HbA1c level of 7.0%-10.0%, a BMI of 23-45 kg/m², and an estimated glomerular filtration rate (eGFR) greater than 45 mL/min/1.73 m². Participants will be recruited from the endocrinology outpatient departments of participating tertiary hospitals in Bangladesh. A total of 200 eligible participants will be enrolled and randomly assigned in a 1:1 ratio to receive either empagliflozin 10 mg once daily in addition to standard treatment or standard treatment alone. Participants will be followed for 12 weeks, with assessments conducted at baseline, Week 4, and Week 12.
Who may be able to join
- Adults aged 18 years or older. Clinically diagnosed type 2 diabetes mellitus. Diagnosis of nonalcoholic fatty liver disease. Stable antidiabetic treatment before study enrollment. Eligible for treatment with empagliflozin. Willingness to participate in the study. Ability to provide written informed consent.
Who cannot join
- Type 1 diabetes mellitus. History of diabetic ketoacidosis. Significant chronic liver disease other than nonalcoholic fatty liver disease. Decompensated liver disease or cirrhosis. Severe renal impairment or contraindications to empagliflozin. Current use of another SGLT2 inhibitor. Pregnancy or breastfeeding. Known hypersensitivity to empagliflozin. Any condition considered by the investigator to interfere with study participation or outcome assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Empagliflozin on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
This prospective, open-label, randomized clinical study will evaluate the effect of empagliflozin 10 mg daily, added to standard T2DM treatment, on liver fat and hepatic parameters in adults with type 2 diabetes and nonalcoholic fatty liver disease. Two hundred eligible participants will be randomized 1:1 to empagliflozin plus standard therapy or standard therapy alone and followed for 12 weeks. The primary outcome is change in liver fat assessed by liver ultrasonography. Secondary outcomes include changes in ALT, AST, AST/ALT ratio, AP index, APRI, FIB-4, NFS, and BARD scores.
Read the detailed description
Type 2 diabetes mellitus (T2DM) frequently coexists with nonalcoholic fatty liver disease (NAFLD), and the presence of T2DM may increase the risk of progression of NAFLD to more advanced liver disease. This study is designed to evaluate whether empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor used for the treatment of T2DM, has an effect on liver fat and selected non-invasive markers of hepatic injury and fibrosis. The rationale for the study is based on the potential effects of SGLT-2 inhibition on glucose metabolism, insulin resistance, and hepatic steatosis.
Eligible adults with T2DM and NAFLD will be recruited from endocrinology outpatient departments of participating tertiary hospitals in Bangladesh. Participants will be randomly allocated in a 1:1 ratio to receive either empagliflozin 10 mg once daily in addition to standard treatment for T2DM or standard treatment without empagliflozin. The study will use an open-label treatment allocation, while investigators involved in imaging assessment will be blinded to participant information and treatment allocation.
The planned sample size is 200 participants, with 100 participants allocated to each treatment group. Participants will undergo baseline assessment and follow-up at weeks 4 and 12. Clinical and laboratory assessments will include anthropometric measurements, glycaemic parameters, lipid profile, renal function, liver enzymes, complete blood count, and liver ultrasonography.
The primary outcome is the change in liver fat from baseline, assessed by liver ultrasonography. Secondary outcomes include changes in ALT, AST, AST/ALT ratio, age-platelet (AP) index, AST-to-platelet ratio index (APRI), Fibrosis-4 (FIB-4), NAFLD fibrosis score (NFS), and BARD score.
Participants will be adults aged 18 years or older with T2DM and NAFLD, HbA1c between 7.0% and 10.0%, BMI between 23 and 45 kg/m², and estimated GFR greater than 45 mL/min/1.73 m². Individuals with other significant liver diseases, cirrhosis or hepatocellular carcinoma, contraindications to empagliflozin, current use of SGLT-2 inhibitors or specified glucose-lowering agents affecting liver fat, acute illness, pregnancy, puerperium or lactation will be excluded.
Data will be collected using a structured case report form. Statistical analyses will be performed using SPSS version 26.0, with appropriate descriptive and comparative statistical tests used to assess differences between the treatment groups. A two-sided p value of less than 0.05 will be considered statistically significant.
- Being tested
- Empagliflozin 10/15 mg administered orally once daily in addition to standard treatment for type 2 diabetes mellitus.
- Keywords
- Type 2 diabetes mellitus, Nonalcoholic fatty liver disease, Empagliflozin, Sodium-glucose cotransporter-2 inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10/15 mg administered orally once daily in addition to standard treatment for type 2 diabetes mellitus.Drug
Empagliflozin 10 mg will be administered orally once daily in addition to standard treatment for type 2 diabetes mellitus (T2DM) for 12 weeks. Participants assigned to this intervention will receive empagliflozin throughout the treatment period, with assessments conducted at baseline, Week 4, and Week 12
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin 10 and 15 mg + Standard Therapy | Standard Therapy Alone (Control) Receives: Drug: Empagliflozin 10/15 mg administered orally once daily in addition to standard treatment for type 2 diabetes mellitus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BARD Score
Change in the BARD score (Body mass index, AST/ALT ratio, and Diabetes) from baseline to the end of the intervention period. The BARD score ranges from 0 to 4, with higher scores indicating a greater likelihood of advanced liver fibrosis.
Measured: 12 weeks after randomization
Change in liver fat
Change in serum alanine aminotransferase (ALT). Change in serum aspartate aminotransferase (AST). Change in AST/ALT ratio. Change in AST-to-platelet ratio index (APRI). Change in Fibrosis-4 (FIB-4) index. Change in NAFLD Fibrosis Score (NFS). Change in age-platelet (AP) index. Change in BARD score, if not retained as a primary outcome.
Measured: 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 792 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahjada Selim, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Shahjada Selim, MD, Study chair, Dr. Shahjada Selim Role: Principal Investigator / Study Official Affiliation: Department of Endocrinology, Bangladesh Medical University (BMU), Dhaka, Bangladesh Email: selimshahjada@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915596
- Sponsor's protocol ID
- BSMMU-2022-9038
- Acronym
- EMPA-LIVER
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data (IPD) will not be shared with other researchers because the study protocol does not include a plan for external sharing of participant-level data. Data will be used for the purposes specified in the study protocol and managed in accordance with applicable ethical, privacy, and institutional requirements.
Publications
Kuchay MS, Krishan S, Mishra SK, Farooqui KJ, Singh MK, Wasir JS, Bansal B, Kaur P, Jevalikar G, Gill HK, Choudhary NS, Mithal A. Effect of Empagliflozin on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial (E-LIFT Trial). Diabetes Care. 2018 Aug;41(8):1801-1808. doi: 10.2337/dc18-0165. Epub 2018 Jun 12.
PubMed 29895557
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empagliflozin on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07915596
- Acronym / sponsor ID
- EMPA-LIVER / BSMMU-2022-9038
- Keywords
- Type 2 diabetes mellitus, Nonalcoholic fatty liver disease, Empagliflozin, Sodium-glucose cotransporter-2 inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Nov 2026 (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.
This prospective, open-label, randomized clinical study will evaluate the effect of empagliflozin 10 mg daily, added to standard T2DM treatment, on liver fat and hepatic parameters in adults with type 2 diabetes and nonalcoholic fatty liver disease. Two hundred eligible participants will be randomized 1:1 to empagliflozin plus standard therapy or standard therapy alone and followed for 12 weeks. The primary outcome is change in liver fat assessed by liver ultrasonography. Secondary outcomes include changes in ALT, AST, AST/ALT ratio, AP index, APRI, FIB-4, NFS, and BARD scores.
Detailed description
Type 2 diabetes mellitus (T2DM) frequently coexists with nonalcoholic fatty liver disease (NAFLD), and the presence of T2DM may increase the risk of progression of NAFLD to more advanced liver disease. This study is designed to evaluate whether empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor used for the treatment of T2DM, has an effect on liver fat and selected non-invasive markers of hepatic injury and fibrosis. The rationale for the study is based on the potential effects of SGLT-2 inhibition on glucose metabolism, insulin resistance, and hepatic steatosis.
Eligible adults with T2DM and NAFLD will be recruited from endocrinology outpatient departments of participating tertiary hospitals in Bangladesh. Participants will be randomly allocated in a 1:1 ratio to receive either empagliflozin 10 mg once daily in addition to standard treatment for T2DM or standard treatment without empagliflozin. The study will use an open-label treatment allocation, while investigators involved in imaging assessment will be blinded to participant information and treatment allocation.
The planned sample size is 200 participants, with 100 participants allocated to each treatment group. Participants will undergo baseline assessment and follow-up at weeks 4 and 12. Clinical and laboratory assessments will include anthropometric measurements, glycaemic parameters, lipid profile, renal function, liver enzymes, complete blood count, and liver ultrasonography.
The primary outcome is the change in liver fat from baseline, assessed by liver ultrasonography. Secondary outcomes include changes in ALT, AST, AST/ALT ratio, age-platelet (AP) index, AST-to-platelet ratio index (APRI), Fibrosis-4 (FIB-4), NAFLD fibrosis score (NFS), and BARD score.
Participants will be adults aged 18 years or older with T2DM and NAFLD, HbA1c between 7.0% and 10.0%, BMI between 23 and 45 kg/m², and estimated GFR greater than 45 mL/min/1.73 m². Individuals with other significant liver diseases, cirrhosis or hepatocellular carcinoma, contraindications to empagliflozin, current use of SGLT-2 inhibitors or specified glucose-lowering agents affecting liver fat, acute illness, pregnancy, puerperium or lactation will be excluded.
Data will be collected using a structured case report form. Statistical analyses will be performed using SPSS version 26.0, with appropriate descriptive and comparative statistical tests used to assess differences between the treatment groups. A two-sided p value of less than 0.05 will be considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin 10 and 15 mg + Standard Therapy | – | Drug: Empagliflozin 10/15 mg administered orally once daily in addition to standard treatment for type 2 diabetes mellitus.Standard Therapy Alone (Control) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise adults aged 18 years or older with type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) who meet the predefined eligibility criteria. Eligible participants will have an HbA1c level of 7.0%-10.0%, a BMI of 23-45 kg/m², and an estimated glomerular filtration rate (eGFR) greater than 45 mL/min/1.73 m². Participants will be recruited from the endocrinology outpatient departments of participating tertiary hospitals in Bangladesh. A total of 200 eligible participants will be enrolled and randomly assigned in a 1:1 ratio to receive either empagliflozin 10 mg once daily in addition to standard treatment or standard treatment alone. Participants will be followed for 12 weeks, with assessments conducted at baseline, Week 4, and Week 12.
Key inclusion criteria (1 listed)
- Adults aged 18 years or older. Clinically diagnosed type 2 diabetes mellitus. Diagnosis of nonalcoholic fatty liver disease. Stable antidiabetic treatment before study enrollment. Eligible for treatment with empagliflozin. Willingness to participate in the study. Ability to provide written informed consent.
Key exclusion criteria (1 listed)
- Type 1 diabetes mellitus. History of diabetic ketoacidosis. Significant chronic liver disease other than nonalcoholic fatty liver disease. Decompensated liver disease or cirrhosis. Severe renal impairment or contraindications to empagliflozin. Current use of another SGLT2 inhibitor. Pregnancy or breastfeeding. Known hypersensitivity to empagliflozin. Any condition considered by the investigator to interfere with study participation or outcome assessment.
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 |
|---|---|---|
| Empagliflozin 10/15 mg administered orally once daily in addition to standard treatment for type 2 diabetes mellitus.Empagliflozin 10 mg will be administered orally once daily in addition to standard treatment for type 2 diabetes mellitus (T2DM) for 12 weeks. Participants assigned to this intervention will receive empagliflozin throughout the treatment period, with assessments conducted at baseline, Week 4, and Week 12 | Drug | Empagliflozin 10 and 15 mg + Standard Therapy |
Primary outcome
Change in BARD Score
Time frame: 12 weeks after randomization
Change in the BARD score (Body mass index, AST/ALT ratio, and Diabetes) from baseline to the end of the intervention period. The BARD score ranges from 0 to 4, with higher scores indicating a greater likelihood of advanced liver fibrosis.
Change in liver fat
Time frame: 24 weeks after randomization
Change in serum alanine aminotransferase (ALT). Change in serum aspartate aminotransferase (AST). Change in AST/ALT ratio. Change in AST-to-platelet ratio index (APRI). Change in Fibrosis-4 (FIB-4) index. Change in NAFLD Fibrosis Score (NFS). Change in age-platelet (AP) index. Change in BARD score, if not retained as a primary outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 29895557Kuchay MS, Krishan S, Mishra SK, Farooqui KJ, Singh MK, Wasir JS, Bansal B, Kaur P, Jevalikar G, Gill HK, Choudhary NS, Mithal A. Effect of Empagliflozin on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial (E-LIFT Trial). Diabetes Care. 2018 Aug;41(8):1801-1808. doi: 10.2337/dc18-0165. Epub 2018 Jun 12.
- This publication reports a randomized controlled trial evaluating the effect of empagliflozin on liver fat in patients with type 2 diabetes mellitus and nonalcoholic fatty liver disease. It provides directly relevant evidence supporting the rationale andLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant-level data (IPD) will not be shared with other researchers because the study protocol does not include a plan for external sharing of participant-level data. Data will be used for the purposes specified in the study protocol and managed in accordance with applicable ethical, privacy, and institutional requirements.
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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.
Shahjada Selim, MD study chair
Dr. Shahjada Selim Role: Principal Investigator / Study Official Affiliation: Department of Endocrinology, Bangladesh Medical University (BMU), Dhaka, Bangladesh Email: selimshahjada@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 Bangladesh. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BARD Score (time frame: 12 weeks after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07915596, which also lists 1 linked publication.
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 4 Nov 2026.