Diabetes MellitusPhase 1/2NCT07020377
Dapagliflozin in Nonalcoholic Fatty Liver Disease (NAFLD) and Type 2 Diabetes Mellitus Patients (T2DM).
A Phase 1/2 study testing Dapagliflozin (DAPA) in people with Diabetes Mellitus and Non Alcholic Fatty Liver Disease, run by Amira Bisher,PhD at 2 sites in Egypt.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) encompasses conditions such as nonalcoholic steatohepatitis (NASH), which involves liver inflammation and fibrosis resulting from steatosis, potentially leading to cirrhosis and hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Non Alcholic Fatty Liver Disease
- What is being tested?
- Dapagliflozin (DAPA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jan 2024to 30 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 diabetes mellitus patients.
- Patients were having fatty liver changes by fibro scan and with mild to moderate elevation of serum liver enzymes or without.
- patients taking insulin or anti-diabetic medications.
- Patients have Renal dysfunction.
- Patients have Cardiac problem
Who cannot join
- Patients with a history of alcohol, smoking, uncontrolled diabetes.
- Pregnancy.
- Lactation.
- Chronic liver and decompensated liver disease in hepatitis B and C.
- patients whose abdominal ultrasounds findings were extremely abnormal (mass, fibrosis, ascites, and cirrhosis) and amino transaminase levels were severely high (ALT and AST greater than 15 times the upper limit of normal according to Johns Hopkins Diabetes Guide) suggest severe liver cell injury was also worked for acute viral hepatitis.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Egyptian liver hospital
Al Mansurah
Alexandria university main hospital
Alexandria
About this study
Official title: The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)
Nonalcoholic fatty liver disease (NAFLD) encompasses conditions such as nonalcoholic steatohepatitis (NASH), which involves liver inflammation and fibrosis resulting from steatosis, potentially leading to cirrhosis and hepatocellular carcinoma. NAFLD is intricately linked to metabolic syndrome, with insulin resistance and hyperinsulinemia as key underlying factors. particularly among individuals with type2 diabetes. NAFLD is an independent risk factor for cardiovascular events, negatively impacting life expectancy in diabetic patients, and it exacerbates insulin resistance and glucose intolerance.
Early intervention in diabetes complicated by NAFLD is vital due to associations with hepatocarcinogenesis and macrovascular complications. Sodium-glucose cotransporter2 (SGLT2) inhibitors, which promote glucose excretion and reduce insulin dependence, have shown significant hypoglycemic effects, weight reduction, and potential benefits on liver function. Dapagliflozin, a specific SGLT2 inhibitor, has been proven effective in lowering hyperglycemia in type 2 diabetes and mitigating NAFLD-related complications in animal models. This study aimed to evaluate the impact of dapagliflozin on liver function in NAFLD patients with type2 diabetes. Eligible participants received dapagliflozin for 24weeks, with assessments including body composition, serum biochemistry, and molecular parameters to determine therapeutic outcomes.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) is a general term that includes nonalcoholic steatohepatitis (NASH), which is inflammation and fibrosis that accompany steatosis and can lead to hepatic cirrhosis and hepatocellular carcinoma, as well as nonalcoholic fatty liver, which is steatosis affecting hepatocytes. including diseases including diabetes, dyslipidemia, hypertension, and poor glucose tolerance, NAFLD is closely linked to metabolic syndrome due to underlying insulin resistance and related hyperinsulinemia. Thus, NAFLD can be thought of as the metabolic syndrome's hepatic manifestation. Furthermore, between 30 and 70 percent of Egyptians have NAFLD, a consequence of type 2 diabetes. NAFLD has been demonstrated to be an independent risk factor for cardiovascular events that are directly linked to the life expectancies of diabetic patients. It also aggravates insulin resistance and plays a significant role in the decline of glucose tolerance. It is crucial to carry out early and suitable therapeutic interventions for type 2 diabetes complicated by NAFLD because disorders encompassing NAFLD/NASH are closely linked to hepatocarcinogenesis and macrovascular events, which lower life expectancy in patients with diabetes. Oral hypoglycemic medications known as sodium-glucose cotransporter 2 (SGLT2) inhibitors work in a unique way by increasing the excretion of glucose in the urine and blocking the reabsorption of glucose in the proximal renal tubule. This lowers blood sugar levels without the need for insulin. SGLT2 inhibitors not only have a great hypoglycemic impact but also lower body weight and blood glucose. Additionally, they have allegedly demonstrated positive benefits on hepatic dysfunction in both clinical trials and animal models, as well as pleiotropic effects on a variety of problems and regulatory effects on macrovascular events. Therefore, when utilized to treat patients with type 2 diabetes aggravated by NAFLD, SGLT2 inhibitors should show efficacy. It has been demonstrated that dapagliflozin, a strong and specific SGLT2 inhibitor, lowers hyperglycemia in T2DM patients. In rat models, dapagliflozin has also been shown to lessen some of the problems related to NAFLD. Thus, in this study, we assessed how dapagliflozin affected the liver function of NAFLD patients with type 2 diabetes. Dapagliflozin was given to eligible individuals for 24 weeks, and body composition tests, serum biochemistry measurements, and molecular parameters were used to assess the medication's therapeutic benefits.
- Being tested
- Dapagliflozin (DAPA), Placebo, Negative control
- Keywords
- Diabetes mellitus type 2, non alcoholic fatty liver disease, hepato-protective, Dapagliflozin
- Medical subject headings
- Diabetes Mellitus, 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.
Dapagliflozin (DAPA)Drug
dapagliflozin 10mg tab once daily for NAFLD patient
PlaceboDrug
placebo
Negative controlOther
Baseline sample serum without either drug or placebo
| Study group | Role | What they receive |
|---|---|---|
| Positive control | Placebo comparator | Not described Receives: Drug: Placebo |
| Dapagliflozin 10mg | Active comparator | The group which takes the medication (dapagliflozin) Receives: Drug: Dapagliflozin (DAPA) |
| Negative control | Other | healthy participants without any medication Receives: Other: Negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroscan
Decrease in liver stiffness by measure CAP
Measured: 6 months
soluble vascular cell adhesion molecule-1 (Svcam-1)
VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.
Measured: 6 months
adiponectin
adiponectin by enzyme-linked immunosorbent assay (ELISA).
Measured: 6 months
leptin
leptin by enzyme-linked immunosorbent assay (ELISA).
Measured: 6 months
Secondary outcomes (2)
liver enzymes
ALT (alanine transaminase) and AST (aspartate transaminase)
Measured: 6 months
Lipid profile
Cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL), Triglycerides
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Jan 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amira Bisher,PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University, Egyptian Liver Hospital
- Responsible party
- Sponsor-investigator, Amira Bisher,PhD, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020377
- Sponsor's protocol ID
- Dapagliflozin NAFLD
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.
PubMed 20609968Wu JH, Foote C, Blomster J, Toyama T, Perkovic V, Sundstrom J, Neal B. Effects of sodium-glucose cotransporter-2 inhibitors on cardiovascular events, death, and major safety outcomes in adults with type 2 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2016 May;4(5):411-9. doi: 10.1016/S2213-8587(16)00052-8. Epub 2016 Mar 18.
PubMed 27009625Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
PubMed 26378978Targher G, Day CP, Bonora E. Risk of cardiovascular disease in patients with nonalcoholic fatty liver disease. N Engl J Med. 2010 Sep 30;363(14):1341-50. doi: 10.1056/NEJMra0912063. No abstract available.
PubMed 20879883Tomah S, Hamdy O, Abuelmagd MM, Hassan AH, Alkhouri N, Al-Badri MR, Gardner H, Eldib AH, Eid EA. Prevalence of and risk factors for non-alcoholic fatty liver disease (NAFLD) and fibrosis among young adults in Egypt. BMJ Open Gastroenterol. 2021 Oct;8(1):e000780. doi: 10.1136/bmjgast-2021-000780.
PubMed 34610926Lomonaco R, Ortiz-Lopez C, Orsak B, Finch J, Webb A, Bril F, Louden C, Tio F, Cusi K. Role of ethnicity in overweight and obese patients with nonalcoholic steatohepatitis. Hepatology. 2011 Sep 2;54(3):837-45. doi: 10.1002/hep.24483. Epub 2011 Aug 8.
PubMed 21674556Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.
PubMed 15565570
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT07020377
- Acronym / sponsor ID
- Dapagliflozin NAFLD
- Keywords
- Diabetes mellitus type 2, non alcoholic fatty liver disease, hepato-protective, Dapagliflozin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Amira Bisher,PhDUniversity, hospital or other
- Collaborators
- Alexandria University, Egyptian Liver Hospital
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 Jun 2025 (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.
Nonalcoholic fatty liver disease (NAFLD) encompasses conditions such as nonalcoholic steatohepatitis (NASH), which involves liver inflammation and fibrosis resulting from steatosis, potentially leading to cirrhosis and hepatocellular carcinoma. NAFLD is intricately linked to metabolic syndrome, with insulin resistance and hyperinsulinemia as key underlying factors. particularly among individuals with type2 diabetes. NAFLD is an independent risk factor for cardiovascular events, negatively impacting life expectancy in diabetic patients, and it exacerbates insulin resistance and glucose intolerance.
Early intervention in diabetes complicated by NAFLD is vital due to associations with hepatocarcinogenesis and macrovascular complications. Sodium-glucose cotransporter2 (SGLT2) inhibitors, which promote glucose excretion and reduce insulin dependence, have shown significant hypoglycemic effects, weight reduction, and potential benefits on liver function. Dapagliflozin, a specific SGLT2 inhibitor, has been proven effective in lowering hyperglycemia in type 2 diabetes and mitigating NAFLD-related complications in animal models. This study aimed to evaluate the impact of dapagliflozin on liver function in NAFLD patients with type2 diabetes. Eligible participants received dapagliflozin for 24weeks, with assessments including body composition, serum biochemistry, and molecular parameters to determine therapeutic outcomes.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is a general term that includes nonalcoholic steatohepatitis (NASH), which is inflammation and fibrosis that accompany steatosis and can lead to hepatic cirrhosis and hepatocellular carcinoma, as well as nonalcoholic fatty liver, which is steatosis affecting hepatocytes. including diseases including diabetes, dyslipidemia, hypertension, and poor glucose tolerance, NAFLD is closely linked to metabolic syndrome due to underlying insulin resistance and related hyperinsulinemia. Thus, NAFLD can be thought of as the metabolic syndrome's hepatic manifestation. Furthermore, between 30 and 70 percent of Egyptians have NAFLD, a consequence of type 2 diabetes. NAFLD has been demonstrated to be an independent risk factor for cardiovascular events that are directly linked to the life expectancies of diabetic patients. It also aggravates insulin resistance and plays a significant role in the decline of glucose tolerance. It is crucial to carry out early and suitable therapeutic interventions for type 2 diabetes complicated by NAFLD because disorders encompassing NAFLD/NASH are closely linked to hepatocarcinogenesis and macrovascular events, which lower life expectancy in patients with diabetes. Oral hypoglycemic medications known as sodium-glucose cotransporter 2 (SGLT2) inhibitors work in a unique way by increasing the excretion of glucose in the urine and blocking the reabsorption of glucose in the proximal renal tubule. This lowers blood sugar levels without the need for insulin. SGLT2 inhibitors not only have a great hypoglycemic impact but also lower body weight and blood glucose. Additionally, they have allegedly demonstrated positive benefits on hepatic dysfunction in both clinical trials and animal models, as well as pleiotropic effects on a variety of problems and regulatory effects on macrovascular events. Therefore, when utilized to treat patients with type 2 diabetes aggravated by NAFLD, SGLT2 inhibitors should show efficacy. It has been demonstrated that dapagliflozin, a strong and specific SGLT2 inhibitor, lowers hyperglycemia in T2DM patients. In rat models, dapagliflozin has also been shown to lessen some of the problems related to NAFLD. Thus, in this study, we assessed how dapagliflozin affected the liver function of NAFLD patients with type 2 diabetes. Dapagliflozin was given to eligible individuals for 24 weeks, and body composition tests, serum biochemistry measurements, and molecular parameters were used to assess the medication's therapeutic benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive control | Placebo comparator | Drug: Placebo |
| Dapagliflozin 10mg | Active comparator | Drug: Dapagliflozin (DAPA)The group which takes the medication (dapagliflozin) |
| Negative control | Other | Other: Negative controlhealthy participants without any medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Type 2 diabetes mellitus patients.
- Patients were having fatty liver changes by fibro scan and with mild to moderate elevation of serum liver enzymes or without.
- patients taking insulin or anti-diabetic medications.
- Patients have Renal dysfunction.
- Patients have Cardiac problem
Key exclusion criteria (5 listed)
- Patients with a history of alcohol, smoking, uncontrolled diabetes.
- Pregnancy.
- Lactation.
- Chronic liver and decompensated liver disease in hepatitis B and C.
- patients whose abdominal ultrasounds findings were extremely abnormal (mass, fibrosis, ascites, and cirrhosis) and amino transaminase levels were severely high (ALT and AST greater than 15 times the upper limit of normal according to Johns Hopkins Diabetes Guide) suggest severe liver cell injury was also worked for acute viral hepatitis.
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 |
|---|---|---|
| Dapagliflozin (DAPA)dapagliflozin 10mg tab once daily for NAFLD patient | Drug | Dapagliflozin 10mg |
| Placeboplacebo | Drug | Positive control |
| Negative controlBaseline sample serum without either drug or placebo | Other | Negative control |
Primary outcome
Fibroscan
Time frame: 6 months
Decrease in liver stiffness by measure CAP
soluble vascular cell adhesion molecule-1 (Svcam-1)
Time frame: 6 months
VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.
adiponectin
Time frame: 6 months
adiponectin by enzyme-linked immunosorbent assay (ELISA).
leptin
Time frame: 6 months
leptin by enzyme-linked immunosorbent assay (ELISA).
2 secondary outcomes
liver enzymes
Time frame: 6 months
Lipid profile
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 20609968Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Jun 26;375(9733):2223-33. doi: 10.1016/S0140-6736(10)60407-2.
- Background: PubMed 27009625Wu JH, Foote C, Blomster J, Toyama T, Perkovic V, Sundstrom J, Neal B. Effects of sodium-glucose cotransporter-2 inhibitors on cardiovascular events, death, and major safety outcomes in adults with type 2 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2016 May;4(5):411-9. doi: 10.1016/S2213-8587(16)00052-8. Epub 2016 Mar 18.
- Background: PubMed 26378978Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
- Background: PubMed 20879883Targher G, Day CP, Bonora E. Risk of cardiovascular disease in patients with nonalcoholic fatty liver disease. N Engl J Med. 2010 Sep 30;363(14):1341-50. doi: 10.1056/NEJMra0912063. No abstract available.
- Background: PubMed 34610926Tomah S, Hamdy O, Abuelmagd MM, Hassan AH, Alkhouri N, Al-Badri MR, Gardner H, Eldib AH, Eid EA. Prevalence of and risk factors for non-alcoholic fatty liver disease (NAFLD) and fibrosis among young adults in Egypt. BMJ Open Gastroenterol. 2021 Oct;8(1):e000780. doi: 10.1136/bmjgast-2021-000780.
- Background: PubMed 21674556Lomonaco R, Ortiz-Lopez C, Orsak B, Finch J, Webb A, Bril F, Louden C, Tio F, Cusi K. Role of ethnicity in overweight and obese patients with nonalcoholic steatohepatitis. Hepatology. 2011 Sep 2;54(3):837-45. doi: 10.1002/hep.24483. Epub 2011 Aug 8.
- Background: PubMed 15565570Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dapagliflozin (DAPA) in people with Diabetes Mellitus and Non Alcholic Fatty Liver Disease, run by Amira Bisher,PhD at 2 sites in Egypt.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Fibroscan (time frame: 6 months). The study lists 4 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 NCT07020377, which also lists 7 linked publications.
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 13 Jun 2025.