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CompletedNCT05459701Updated Feb 4, 2025

Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

A Phase 4 interventional study of Dapagliflozin 10mg Tab and Placebo in Nonalcoholic Fatty Liver Disease and Type 2 Diabetes, sponsored by Rehab Werida. Completed at 1 site in Egypt. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Rehab Werida · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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
  1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
  2. Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
  3. 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.
  4. All participants should agree to take part in this clinical study and will provide informed consent.
  5. Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
  6. 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).

  7. Measuring outcome:

    1. 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).
    2. The molecular tests will be done on the patient are soluble vascular cell adhesion molecule-1 (Svcam-1), adipocytes (e.g. adiponectin, leptin).
  8. The ultrasound screening will be done at first examination.
  9. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
  10. Results, conclusion, discussion and recommendations will be given.
02

Conditions studied

  • Nonalcoholic Fatty Liver Disease
  • Type 2 Diabetes
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Rehab Werida is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Type 2 diabetes mellitus patients.
  2. HbA1C \< 8.5.
  3. Patients were They were having fatty liver changes on abdominal ultrasound and mild to moderate elevation of serum liver enzymes.
  4. BMI more than 30

Exclusion criteria

Exclusion Criteria:

  1. Patients with a history of alcohol, smoking, uncontrolled diabetes.
  2. (HbA1c > 9.0).
  3. Pregnancy.
  4. Lactation.
  5. Hemochromatosis.
  6. Thyroid disorders.
  7. Renal dysfunction.
  8. Cardiac problem.
  9. Chronic liver and decompensated liver disease in the form of hepatitis B and C.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Placebo comparator
    group (A) for controlled (placebo).

    25 patients will recieve placebo for 6 months.

    Other: Placebo

  • Active comparator
    group (D) for Dapagliflozin.

    25 patients will recieve 10 mg Dapagliflozin daily for 6 months.

    Drug: Dapagliflozin 10mg Tab

Interventions

  • DrugDapagliflozin 10mg Tab

    Dapagliflozin 10 mg once daily for 24 weeks.

    Also known as: Dapagliflozin 10 mg.

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. leptin (ng/ml)

    leptin by enzyme-linked immunosorbent assay (ELISA).

    Time frame: 6 months

  2. adiponectin (pg/ml)

    adiponectin by enzyme-linked immunosorbent assay (ELISA).

    Time frame: 6 months

  3. VCAM-1 (ng/ml)

    VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.

    Time frame: 6 months

07

Study locations

1 site
  • Rehab Hussein Werida
    Damanhūr, Elbehairah 31527, Egypt
08

References and documents

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 26963613 ↗
  • Tahara 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 23707905 ↗
  • Ohki 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05459701
Lead sponsor
Rehab Werida
Collaborators
University of Alexandria
Responsible party
Rehab Werida (Associate Professor, Damanhour University) — Sponsor-investigator
First posted
Jul 15, 2022
Start date
May 1, 2022
Primary completion
Jun 30, 2024
Completion
Jul 31, 2024
Last update
Feb 4, 2025

Study contacts

Rehab H Werida, Ass Prof.
study chair · Damanhour University
Amira B. Kassem, Lecturer
principal investigator · Damanhour University
Yasmin Essam, Bachlor
principal investigator · Damanhour University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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