Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease

NCT05422092 | Unknown

• 1 other identifier: 21YXYJ0111
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type 2 diabetes mellitus (T2DM) is always accompanied with nonalcoholic fatty liver disease (NAFLD).This prospective, randomized controlled intervention study was designed to reveal the potential clinical application and underlying mechanisms of canagliflozin in the treatment of type 2 diabetes combined with nonalcoholic fatty liver disease.

Conditions

Type 2 Diabetes Mellitus With Complication

Outcome Measures

Primary Outcomes (2)

• Plasma cholesteryl ester transfer protein(CETP) concentration in ug/mL

  Measurements of liver inflammation and damage

  24 weeks after the date of enrollment

• The activity of CEPT in pmol/mL/min

  Measurements of liver inflammation and damage

  24 weeks after the date of enrollment

Secondary Outcomes (2)

• Plasma cholesteryl ester transfer protein(CETP) concentration in ug/mL

  Baseline

• The activity of CEPT in pmol/mL/min

  Baseline

Study Arms (2)

Canagliflozin treatment group

EXPERIMENTAL

Canagliflozin 100mg were given to the patients for 24 weeks

Drug: Canagliflozin

Pioglitazone treatment group

PLACEBO COMPARATOR

Pioglitazone 30mg were given to the patients and the dosage will be increased to 45mg 2 weeks later

Drug: Pioglitazone

Interventions

Canagliflozin DRUG

40 patients with T2DM combined with NAFLD, who have poor glycemic control response to metformin monotherapy, will be randomly assigned to receive canagliflozin on top of metformin as experimental group.

Also known as: Canagliflozin tablets

Canagliflozin treatment group

Pioglitazone DRUG

40 patients with T2DM combined with NAFLD, who have poor glycemic control response to metformin monotherapy, will be randomly assigned to receive pioglitazone 45mg on top of metformin as placebo comparator group.

Also known as: Pioglitazone Hydrochloride Tablets

Pioglitazone treatment group

Eligibility Criteria

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

You may qualify if:

• Meets the diagnostic criteria for type 2 diabetes(1999 WHO criteria).
• Meets the diagnostic criteria for non-alcoholic fatty liver disease (2018 Chinese Medical Association Treatment Guidelines ), and liver ultrasound showed moderate or higher fatty liver.
• Metformin monotherapy for 3 months, but with poor glycemic control (7.5%≤HbA1c≤10.5%))
• Obese or overweight when screening (BMI\>24kg/m2);
• years old ≤ age ≤ 70 years old;
• Have a good follow-up compliance, with follow-up months ≥ 24 weeks;

You may not qualify if:

• Non-type 2 diabetes: type 1 diabetes, gestational diabetes, or other specific types of diabetes;
• Diabetes patients with acute and chronic complications and serious infections; Pregnant and lactating women;
• Those who have allergies or toxic side effects or contraindications to canagliflozin, pioglitazone and other drugs;
• Active sexually transmitted diseases such as viral hepatitis, AIDS and syphilis, and infectious diseases such as tuberculosis;
• Have a weight change of more than 10% in the 3 months prior to screening;
• Have used other drugs that may affect blood glucose metabolism in the past 2 months, including systemic glucocorticoids (except inhalation or topical use), growth hormone, etc.;
• Have used any sodium-glucose cotransporter-2 (SGLT-2) inhibitor or thiazolidinediones;
• History of more than 2 severe hypoglycemic episodes in the past 1 year;
• History or condition of any of the following: decompensated cardiac insufficiency (NYHA class III or IV); history of unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stenting; uncontrolled or severe heart rhythm Disorders (such as long QT syndrome, etc.), and evaluated by the investigator to be unsuitable to participate in this clinical trial; currently accompanied by clinically significant urinary tract/reproductive infection, or a history of complicated urinary tract infection, or nearly 6 A history of recurrent urinary tract infections within a month;
• Currently known to have severe osteoporosis, or a history of secondary fractures within the past 1 year;
• Any laboratory tests meet the following criteria: fasting plasma/serum glucose ≥ 15 mmol/L; alanine aminotransferase or aspartate aminotransferase \> 3 times the upper limit of normal or total bilirubin \> 1.5 times normal Upper limit; hemoglobin \<100 g/L; glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2; fasting triglycerides \> 5.64 mmol/L (500 mg/dL);
• Has received or is receiving any other experimental drug/trial device treatment within the past 3 months;
• Other conditions deemed inappropriate by the investigator to participate in this trial.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Interventions

Canagliflozin; Pioglitazone

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Thiazolidinediones; Thiazoles; Azoles

Study Officials

• YAYI He

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YAYI HE

CONTACT

0086-15934880897; 008099@xjtufh.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 16, 2022
• Study Start: September 20, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share