Nonalcoholic Fatty Liver DiseasePhase 4NCT05459701
Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Nonalcoholic Fatty Liver Disease and Type 2 Diabetes, run by Rehab Werida at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Type 2 Diabetes
- What is being tested?
- Dapagliflozin 10mg Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 31 Jul 2024
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus patients.
- HbA1C < 8.5.
- Patients were They were having fatty liver changes on abdominal ultrasound and mild to moderate elevation of serum liver enzymes.
- BMI more than 30
Who cannot join
- Patients with a history of alcohol, smoking, uncontrolled diabetes.
- (HbA1c > 9.0).
- Pregnancy.
- Lactation.
- Hemochromatosis.
- Thyroid disorders.
Show all 9Show fewer
- Renal dysfunction.
- Cardiac problem.
- Chronic liver and decompensated liver disease in the form of hepatitis B and C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)
The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.
Read the detailed description
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
- About 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on non- alcoholic fatty disease, will be recruited from Alexandria Teaching Hospital (EL-Mery), General Organization for Teaching Hospitals and Institutes.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
- Venous blood samples (5 ml will be collected by a sterile syringe then placed in a suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C until the analysis) before, and after receiving medication (Dapagliflozin).
- Measuring outcome:
- The biochemical tests will be done on the patients are alanine aminotransferase (ALT), aspartate aminotransferase (AST), homeostasis model assessment of insulin resistance (HOMA-IR), Hemoglobin A1C (HbA1C), Low-density lipoproteins (LDL), High-density lipoproteins (HDL), Triglycerides (TG), liver fibrosis score, and complete blood count (CBC).
- The molecular tests will be done on the patient are soluble vascular cell adhesion molecule-1 (Svcam-1), adipocytes (e.g. adiponectin, leptin).
- The ultrasound screening will be done at first examination.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
- Conditions
- Nonalcoholic Fatty Liver Disease, Type 2 Diabetes
- Being tested
- Dapagliflozin 10mg Tab, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called Dapagliflozin 10 mg.
Dapagliflozin 10 mg once daily for 24 weeks.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| group (A) for controlled (placebo). | Placebo comparator | 25 patients will recieve placebo for 6 months. Receives: Other: Placebo |
| group (D) for Dapagliflozin. | Active comparator | 25 patients will recieve 10 mg Dapagliflozin daily for 6 months. Receives: Drug: Dapagliflozin 10mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
leptin (ng/ml)
leptin by enzyme-linked immunosorbent assay (ELISA).
Measured: 6 months
adiponectin (pg/ml)
adiponectin by enzyme-linked immunosorbent assay (ELISA).
Measured: 6 months
VCAM-1 (ng/ml)
VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.
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 posted15 Jul 2022
- Study start1 May 2022
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized (1:1), double-blind clinical trial, will be carried out on 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on diabetic type 2 patients with non- alcoholic fatty disease (dapagliflozin 10 mg once daily for 24 - 48 weeks -Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and the other group (D) for Dapagliflozin.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alexandria
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Study chair, Damanhour UniversityAmira B. Kassem, Lecturer, Principal investigator, Damanhour UniversityYasmin Essam, Bachlor, Principal investigator, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459701
- Sponsor's protocol ID
- Dapagliflozin in NAFLD
- Status last verified
- Feb 2025
- First submitted
- 12 Jul 2022
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiba Y, Yamada T, Tsukita S, Takahashi K, Munakata Y, Shirai Y, Kodama S, Asai Y, Sugisawa T, Uno K, Sawada S, Imai J, Nakamura K, Katagiri H. Dapagliflozin, a Sodium-Glucose Co-Transporter 2 Inhibitor, Acutely Reduces Energy Expenditure in BAT via Neural Signals in Mice. PLoS One. 2016 Mar 10;11(3):e0150756. doi: 10.1371/journal.pone.0150756. eCollection 2016.
PubMed 26963613Tahara A, Kurosaki E, Yokono M, Yamajuku D, Kihara R, Hayashizaki Y, Takasu T, Imamura M, Li Q, Tomiyama H, Kobayashi Y, Noda A, Sasamata M, Shibasaki M. Effects of SGLT2 selective inhibitor ipragliflozin on hyperglycemia, hyperlipidemia, hepatic steatosis, oxidative stress, inflammation, and obesity in type 2 diabetic mice. Eur J Pharmacol. 2013 Sep 5;715(1-3):246-55. doi: 10.1016/j.ejphar.2013.05.014. Epub 2013 May 23.
PubMed 23707905Ohki T, Isogawa A, Toda N, Tagawa K. Effectiveness of Ipragliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor, as a Second-line Treatment for Non-Alcoholic Fatty Liver Disease Patients with Type 2 Diabetes Mellitus Who Do Not Respond to Incretin-Based Therapies Including Glucagon-like Peptide-1 Analogs and Dipeptidyl Peptidase-4 Inhibitors. Clin Drug Investig. 2016 Apr;36(4):313-9. doi: 10.1007/s40261-016-0383-1.
PubMed 26914659
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 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
- NCT05459701
- Acronym / sponsor ID
- Dapagliflozin in NAFLD
- Conditions
- Nonalcoholic Fatty Liver Disease, Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Collaborators
- University of Alexandria
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 15 Jul 2022 (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.
The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.
Detailed description
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
- About 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on non- alcoholic fatty disease, will be recruited from Alexandria Teaching Hospital (EL-Mery), General Organization for Teaching Hospitals and Institutes.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
- Venous blood samples (5 ml will be collected by a sterile syringe then placed in a suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C until the analysis) before, and after receiving medication (Dapagliflozin).
- Measuring outcome:
- The biochemical tests will be done on the patients are alanine aminotransferase (ALT), aspartate aminotransferase (AST), homeostasis model assessment of insulin resistance (HOMA-IR), Hemoglobin A1C (HbA1C), Low-density lipoproteins (LDL), High-density lipoproteins (HDL), Triglycerides (TG), liver fibrosis score, and complete blood count (CBC).
- The molecular tests will be done on the patient are soluble vascular cell adhesion molecule-1 (Svcam-1), adipocytes (e.g. adiponectin, leptin).
- The ultrasound screening will be done at first examination.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a prospective, randomized (1:1), double-blind clinical trial, will be carried out on 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on diabetic type 2 patients with non- alcoholic fatty disease (dapagliflozin 10 mg once daily for 24 - 48 weeks -Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and the other group (D) for Dapagliflozin.
| Arm | Type | Receives |
|---|---|---|
| group (A) for controlled (placebo). | Placebo comparator | Other: Placebo25 patients will recieve placebo for 6 months. |
| group (D) for Dapagliflozin. | Active comparator | Drug: Dapagliflozin 10mg Tab25 patients will recieve 10 mg Dapagliflozin daily for 6 months. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus patients.
- HbA1C < 8.5.
- Patients were They were having fatty liver changes on abdominal ultrasound and mild to moderate elevation of serum liver enzymes.
- BMI more than 30
Key exclusion criteria (9 listed)
- Patients with a history of alcohol, smoking, uncontrolled diabetes.
- (HbA1c > 9.0).
- Pregnancy.
- Lactation.
- Hemochromatosis.
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 10mg TabAlso: Dapagliflozin 10 mg.Dapagliflozin 10 mg once daily for 24 weeks. | Drug | group (D) for Dapagliflozin. |
| PlaceboPlacebo | Other | group (A) for controlled (placebo). |
Primary outcome
leptin (ng/ml)
Time frame: 6 months
leptin by enzyme-linked immunosorbent assay (ELISA).
adiponectin (pg/ml)
Time frame: 6 months
adiponectin by enzyme-linked immunosorbent assay (ELISA).
VCAM-1 (ng/ml)
Time frame: 6 months
VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.
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 Feb 2025.
- Background: PubMed 26963613Chiba Y, Yamada T, Tsukita S, Takahashi K, Munakata Y, Shirai Y, Kodama S, Asai Y, Sugisawa T, Uno K, Sawada S, Imai J, Nakamura K, Katagiri H. Dapagliflozin, a Sodium-Glucose Co-Transporter 2 Inhibitor, Acutely Reduces Energy Expenditure in BAT via Neural Signals in Mice. PLoS One. 2016 Mar 10;11(3):e0150756. doi: 10.1371/journal.pone.0150756. eCollection 2016.
- Results publication: PubMed 23707905Tahara A, Kurosaki E, Yokono M, Yamajuku D, Kihara R, Hayashizaki Y, Takasu T, Imamura M, Li Q, Tomiyama H, Kobayashi Y, Noda A, Sasamata M, Shibasaki M. Effects of SGLT2 selective inhibitor ipragliflozin on hyperglycemia, hyperlipidemia, hepatic steatosis, oxidative stress, inflammation, and obesity in type 2 diabetic mice. Eur J Pharmacol. 2013 Sep 5;715(1-3):246-55. doi: 10.1016/j.ejphar.2013.05.014. Epub 2013 May 23.
- Results publication: PubMed 26914659Ohki T, Isogawa A, Toda N, Tagawa K. Effectiveness of Ipragliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor, as a Second-line Treatment for Non-Alcoholic Fatty Liver Disease Patients with Type 2 Diabetes Mellitus Who Do Not Respond to Incretin-Based Therapies Including Glucagon-like Peptide-1 Analogs and Dipeptidyl Peptidase-4 Inhibitors. Clin Drug Investig. 2016 Apr;36(4):313-9. doi: 10.1007/s40261-016-0383-1.
- Individual participant dataSharing planned: No
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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.
Rehab H Werida, Ass Prof. study chair
Damanhour University
Amira B. Kassem, Lecturer principal investigator
Damanhour University
Yasmin Essam, Bachlor principal investigator
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Nonalcoholic Fatty Liver Disease and Type 2 Diabetes, run by Rehab Werida at 1 site 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 4 inclusion and 9 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 Feb 2025. 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 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
leptin (ng/ml) (time frame: 6 months). The study lists 3 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 NCT05459701, which also lists 3 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 4 Feb 2025.