type 2 diabetes mellitus
Conditions
Interventions
Experimental group:iGlarlixi combined with metformin
Sponsors
Drum Tower Hospital Affiliated to Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.T2DM; 2.MRI-PDFF>=10%; 3.At least 3 months treatment of basic insulin and metformin combined with or without other oral antidiabetic drugs except SGLT-2i ( metformin >=1.5g/d or reach the maximum tolerated dose); 4.BMI 20~35 kg/m^2 and with a history of stable body weight (=3 months); 5.30-75 years old; 6.5%<HbA1c <=8.0%.
Exclusion criteria
Exclusion criteria: 1. Use of orlistat or any other drugs related to hepatic steatosis (including but not limited to glucocorticoids, tamoxifen, amiodarone, or methotrexate) within the past 3 months; 2. During screening, any clinically significant abnormality found in physical examination, laboratory tests, or vital signs, or any serious systemic disease that may shorten expected lifespan and is considered by the investigator to potentially limit/hinder the patient from completing the study, including: acute infections such as acute cholecystitis, appendicitis, acute abdominal infection, acute gastroenteritis, acute upper respiratory tract infection, acute urinary tract infection (within 2 weeks); acute complications of diabetes including diabetic ketoacidosis, hyperosmolar hyperglycemic state, hypoglycemic coma, etc.; history of pancreatitis or other pancreatic diseases, with amylase and/or lipase levels >3 times the upper limit of normal; liver dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal; moderate to severe renal impairment, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²; congestive heart failure (NYHA III–IV). 3. History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2); 4. Severe gastrointestinal diseases; 5. Contraindications to MRI examination, such as metal implants in the body, claustrophobia, etc.; 6. Pregnant or breastfeeding women; 7. Currently receiving or having received other investigational drugs within 6 months prior to this study; 8. Known or suspected allergy to the investigational drug or similar drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI-PDFF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function indicators;Liver fibrosis;Liver inflammation;Inbody;Glucose metabolism index;Lipid metabolism index;Kidney function indicators; | — |
Countries
China
Contacts
Public ContactWenjuan Tang
Drum Tower Hospital Affiliated to Nanjing University Medical School
Outcome results
None listed