An observational study in Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Observational
Among 12 studies in Diabetes Mellitus, Type 2 with a site in Bangladesh — 4 open to participants now, 5 under way, 2 of them phase 3. Diabetes Mellitus, Type 2 · Bangladesh.
Among the 12 studies in Diabetes Mellitus, Type 2 with a site in Bangladesh, this one is one of 2 that started in 2023, is one of 6 observational ones, and was the 12th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 792 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →4 of the 12 studies in Diabetes Mellitus, Type 2 with a site in Bangladesh are open now, in 1 country. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2023.
Median enrollment 460 across the 6 interventional studies, 2,092 across the 6 observational. Of the 7 that completed or were terminated, 2 (29%) have results posted.
5 of 12 have an industry lead sponsor. The 8 most frequent:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh has 2 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Diabetes Mellitus, Type 2 with a site in Bangladesh, from their registry updates:
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
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 to empagliflozin. Current use of another SGLT2 inhibitor. Pregnancy or breastfeeding. Known to empagliflozin. Any condition considered by the investigator to interfere with study participation or outcome assessment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Therapy Alone (Control)
Drug: 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
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.
Time frame: 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.
Time frame: 24 weeks after randomization
Plan to share: 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.
Ran from Jan 2023 to primary completion in Dec 2023, 11 months.
Of 432 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 96. This study's 11 months is below that.
Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh →