Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD

NCT07778719 · tracked via the Priya Life Science China tracker

Sponsor

The 95th Hospital of Putian，Putian, Fujian, China

Phase

Not applicable

Started

2026-10-01

Last updated

2026-08-21

Condition(s) studied

Type 2 DiabetesMetabolic Dysfunction-Associated Steatotic Liver Disease

Investigational drug(s) / intervention(s)

Metformin + DapagliflozinMetformin

Metformin + Dapagliflozin: Maintain the stable pre-enrollment dose of metformin (≥1500 mg/day or maximum tolerated dose) plus dapagliflozin 10 mg/day orally, administered once daily before breakfast, for 3 consecutive months. Other concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required. Patients should be instructed to maintain stable dietary and exercise habits throughout the study.

Metformin: Maintain the stable pre-enrollment dose of metformin monotherapy (≥1500 mg/day or maximum tolerated dose) for 3 consecutive months. Other concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required. Patients should be instructed to maintain stable dietary and exercise habits throughout the study.

Study summary

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.

Eligibility

Sex

MALE

Min age

30 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: 1. Males aged 30-60 years; 2. Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%; 3. Having received a stable dose of metformin (≥1500 mg/day or the maximum tolerated dose) as monotherapy for at least 8 weeks; 4. 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; 5. No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists; 6. Willing to participate voluntarily and sign the informed consent form. Exclusion Criteria: 1. Type 1 diabetes mellitus or other specific types of diabetes; 2. Weekly alcohol intake exceeding 210g for males; 3. Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.); 4. Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis; 5. Previous or current use of GH preparations or IGF-1 preparations; 6. Baseline estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m²; 7. Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis); 8. Active malignant tumors; 9. Allergy to dapagliflozin or similar drugs; 10. Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months; 11. Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment.

Primary outcome measure(s)

ΔIGF-1 — 12 weeks
The difference in the change value of serum IGF-1 levels (ΔIGF-1) from baseline to 3 months between the two groups.
Changes in non-invasive indicators of liver fibrosis — 12 weeks
Differences in the change values of the FIB-4 index from baseline to 3 months between the two groups

Trial sites (1)

Facility	City	Region	Status
The Ethics Committee of Putian 95 Hospital	Putian	Fujian

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07778719 on ClinicalTrials.gov ↗ ← All trials in China