Henagliflozin in Relieving Type 2 Diabetes With Non-alcoholic Fatty Liver Disease

NCT06218342 | Unknown Phase 4

• 1 other identifier: 2023412
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized, non-blinded clinical trial specifically designed to assess the initial feasibility and efficacy of SGLT2 inhibitors in treating NAFLD among adults diagnosed with type 2 diabetes.

Conditions

Type 2 Diabetes; Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• Ultrasound attenuation parameter (UAP)

  Changes in ultrasound attenuation parameter (UAP) from baseline. Higher UAP correlates with increased severity of steatosis.

  24 weeks

• Liver stiffness measurement (LSM)

  Changes in liver stiffness measurement (LSM) from baseline. Higher LSM values correlate with advancement in the stage of liver fibrosis.

  24 weeks

Secondary Outcomes (8)

• Non-Alcoholic Fatty Liver Disease Fibrosis Score (NFS)

  24 weeks

• Fibrosis Index Based on 4 Factors (FIB-4 Index)

  24 weeks

• Liver fat content

  24 weeks

• Liver enzymes

  24 weeks

• Cholestatic proteins (Chitinase 3-like protein 1, CHI3L1)

  24 weeks

Study Arms (2)

Henagliflozin

EXPERIMENTAL

Participants in this group will receive a combination of lifestyle intervention, background medication, and Henagliflozin. The choice of hypoglycemic drugs within the background medication is restricted to either one, two, or three among metformin, DPP-4 inhibitors, alpha-glucosidase inhibitors, or secretagogues.

Drug: Henagliflozin

Control

OTHER

Participants in this group will receive lifestyle intervention and background medication. The choice of hypoglycemic drugs within the background medication is restricted to either one, two, or three among metformin, DPP-4 inhibitors, alpha-glucosidase inhibitors, or secretagogues.

Other: Background medication

Interventions

Henagliflozin DRUG

Besides lifestyle intervention and background medication, participants will be prescribed Henagliflozin at standard clinical doses.

Henagliflozin

Background medication OTHER

Participants will only receive lifestyle intervention and background medication.

Control

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 70 years old.
• Diagnosed with type 2 diabetes according to World Health Organization (WHO) diagnostic criteria, with evidence of fatty liver on ultrasound, and FIB-4 index \>1.3.
• Willing to participate in this study and sign an informed consent form. In case the subject lacks the ability to read the informed consent form (e.g., illiterate subjects), the informed process must be witnessed by a designated person who will sign the informed consent form.
• Have not used oral antidiabetic medications or have used one to three oral antidiabetic medications (limited to metformin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, alpha-glucosidase inhibitors, or sulfonylureas) with an HbA1c between 7% and 10%, and fasting venous blood glucose ≤13.3 mmol/L.
• Have not used thiazolidinediones (TZDs), sodium-glucose co-transporter-2 inhibitors (SGLT-2i), glucagon-like peptide-1 receptor agonists (GLP-1RA), or other antidiabetic drugs that may affect liver fat content in the last 90 days.
• Weight change of less than 5% in the last 3 months.
• If of childbearing age, must use reliable contraceptive measures.

You may not qualify if:

• Daily alcohol intake of \>30 g in the past 10 years or daily alcohol intake of \>10 g in the last year.
• History of liver diseases such as hepatitis B, chronic hepatitis C, primary biliary cholangitis (PBC), biliary obstruction disorders, drug-induced liver damage, hemochromatosis, liver cirrhosis, autoimmune hepatitis.
• Patients with decompensated liver cirrhosis, concurrent liver cancer, HIV-positive status, or substance abuse.
• Type 1 diabetes.
• Participation in other clinical trials of diabetes treatment drugs in the 3 months prior to the start of this study.
• Occurrence of diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma in the past 6 months.
• Occurrence of unexplained severe hypoglycemic events in the past 6 months (requiring assistance for recovery) or recurrent hypoglycemia: such as experiencing two or more low blood sugar events (blood glucose ≤3.9 mmol/L) in the month before screening.
• Severe heart disease patients, such as New York Heart Association (NYHA) class IV, unstable angina, or history of myocardial infarction.
• Abnormal liver function, with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper normal limit, or total bilirubin (TBIL) greater than 2 times the upper normal limit.
• Chronic kidney damage, with a creatinine level (Cr) \>200 µmol/L or an estimated glomerular filtration rate (eGFR) \<30 mL·min-1.
• Use of corticosteroid medications (excluding short-term topical or inhaled use).
• Patients with malignant tumors, active tuberculosis, or acute/chronic infections.
• Vulnerable populations, including pregnant women, individuals with mental illness, critically ill patients, individuals with cognitive impairments, etc.
• History of recurrent urinary tract infections or genital infections, or allergies to the investigational drug or its components.
• Patients assessed by the clinical doctor as having low blood volume.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

MeSH Terms

Conditions

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

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiaqiang Zhou

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yangchi Yang

CONTACT

+86 571 8600 6811; yyc261@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: January 23, 2024
• Study Start: February 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01