Efficacy and safety of SGLT-2 inhibitor ganagliflozin proline tablets for type 2 diabetes mellitus (T2DM) combined with metabolic associated fatty liver disease (MAFLD)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600121344

Enrollment

Unknown

Registered

2026-03-30

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus combined with metabolic-associated fatty liver disease

Interventions

Control group:basic treatment

Experimental group:basic treatment plus SGLT-2i ganagliflozin proline tablets

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years and =1.7 mmol and =10% 7. Informed about this study and voluntarily signed the informed consent form. 8. If a woman of childbearing age, the pregnancy test must be negative, and she must not be breastfeeding at the screening visit, be able and willing to participate in scheduled visits and follow the study procedures.

Exclusion criteria

Exclusion criteria: 1. Other comorbid liver diseases 2. Patients currently using investigational drugs or GLP-1 therapy 3. Type 1 diabetes or other specific types of diabetes 4. Alcohol consumption: men >30g/day, women >20g/day 5. Allergy to components of the investigational drug 6. Imaging-diagnosed advanced liver fibrosis, cirrhosis, primary liver cancer, or liver stiffness measurement (LSM) >=12 Kpa 7. Patients with severe diseases of the heart, brain, lungs, or hematologic system 8. Patients with swallowing disorders or gastrointestinal diseases (affecting drug absorption) 9. Pregnant or breastfeeding women, or patients/patients’ partners planning pregnancy within six months 10. Use of medications related to treating liver disease or regulating blood glucose and lipid metabolism within the past 4 weeks, or participation in other clinical studies 11. Patients judged by the investigator as unsuitable for this study, including those with other diseases that may interfere with the efficacy evaluation of this study.

Design outcomes

Primary

Measure	Time frame
Steatosis of liver;Liver Stiffness Measurement;	—

Secondary

Measure	Time frame
Liver function;Triglyceride;Blood sugar;Glycated hemoglobin;Fasting insulin;C-peptide;Albumin-to-Creatinine Ratio;Body Mass Index, BMI;Waist-to-Height Ratio, WHtR;waist circumference;	—

Countries

China

Contacts

Public ContactShunchun Chen

Hebei Provincial People's Hospital

1220222716@qq.com+86 150 3072 7728

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026