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

NCT05459701 | Completed Phase 4

• 1 other identifier: Dapagliflozin in NAFLD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.

Conditions

Nonalcoholic Fatty Liver Disease; Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• leptin (ng/ml)

  leptin by enzyme-linked immunosorbent assay (ELISA).

  6 months

• adiponectin (pg/ml)

  adiponectin by enzyme-linked immunosorbent assay (ELISA).

  6 months

• VCAM-1 (ng/ml)

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

  6 months

Study Arms (2)

group (A) for controlled (placebo).

PLACEBO COMPARATOR

25 patients will recieve placebo for 6 months.

Other: Placebo

group (D) for Dapagliflozin.

ACTIVE COMPARATOR

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

Drug: Dapagliflozin 10mg Tab

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin 10 mg once daily for 24 weeks.

Also known as: Dapagliflozin 10 mg.

group (D) for Dapagliflozin.

Placebo OTHER

Placebo

group (A) for controlled (placebo).

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with a history of alcohol, smoking, uncontrolled diabetes.
• (HbA1c \> 9.0).
• Pregnancy.
• Lactation.
• Hemochromatosis.
• Thyroid disorders.
• Renal dysfunction.
• Cardiac problem.
• Chronic liver and decompensated liver disease in the form of hepatitis B and C.

Sponsors & Collaborators

• Rehab Werida: lead
• University of Alexandria: collaborator

Study Sites (1)

Rehab Hussein Werida

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (3)

• 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.

  PMID: 26963613 BACKGROUND

• 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.

  PMID: 23707905 RESULT

• 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.

  PMID: 26914659 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rehab H Werida, Ass Prof.

  Damanhour University

  STUDY CHAIR

• Amira B. Kassem, Lecturer

  Damanhour University

  PRINCIPAL INVESTIGATOR

• Yasmin Essam, Bachlor

  Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)