Adding dapagliflozin to metformin in men with type 2 diabetes and fatty liver disease
Tests dapagliflozin added to metformin, looking at IGF-1 levels in men.
Plain-language title generated from the registry record
Registry title: Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD
Key facts
- Where
- Putian, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 60 years old?
Source: NCT07778719, who can take part
Where in China
- The Ethics Committee of Putian 95 HospitalPutian, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The 95th Hospital of Putian，Putian, Fujian, China
- Trial code
- NCT07778719
- Record updated
- 21 August 2026
- Original description
This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB/m, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg/day for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.Read full original descriptionShow less
Effects of Metformin Combined With Dapagliflozin on Serum IGF-1 Levels in Male Patients With Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease
This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB/m, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg/day for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.
Inclusion: Males aged 30-60 years; Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%; Having received a stable dose of metformin (≥1500 mg/day or the maximum tolerated dose) as monotherapy for at least 8 weeks; Meeting the diagnostic criteria for MASLD: Controlled Attenuation Parameter (CAP) value ≥248 dB/m detected, with the presence of at least one cardiometabolic risk factor; No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists; Willing to participate voluntarily and sign the informed consent form.
Exclusion: Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.); Previous or current use of GH preparations or IGF-1 preparations; Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis); Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months; Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment; Type 1 diabetes mellitus or other specific types of diabetes; Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis; Active malignant tumors; Allergy to dapagliflozin or similar drugs; Baseline estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m²; Weekly alcohol intake exceeding 210g for males.