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Antidiabetic Effects on Intrahepatic Fat
Comparison of Efficacy of Liraglutide, Metformin and Gliclazide MR on Hepatic Lipid Content in Patients With Type 2 Diabetes (T2DM) and Non-alcoholic Fatty Liver (NAFLD)
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
87
actual
Study population
MASH / NAFLD / liver fibrosis, Type 2 diabetes
Key I/E criteria
•BMI 20-35•HbA1c 7-10%
Primary endpoint
•Liver fat content, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age: 18-70 years;
2. Type 2 diabetes mellitus;
3. Not used antidiabetic drugs within 3 months;
4. HbA1c(7-10%);
5. Presence of fatty liver disease (hepatic fat content ≥ 20% by quantitative ultrasonography);
6. Female subjects:post-menopausal women, take contraceptive measures three months before the test screening and can persist throughout the experimental period;
7. Body mass index (BMI) 20-35kg/m2, and stable Weight 3 months(less than 10% volatility);
8. patients signed the informed consent.
Exclusion criteria
1. Used antidiabetic drugs or any other possible hepatic steatosis associated with drugs within the past three months;
2. Suffering from pancreatitis or other pancreatic diseases or have other similar history;
3. GLP-1 analogs or sulfonylurea allergy history;
4. Liver dysfunction (aspartate aminotransferase ≥ 2.5 times of the normalupper limit);
5. Moderate to severe renal insufficiency (eGFR<60ml/min/1.73m2,calculated according to MDRD);
6. Female subjects drinking> 14 units / week; male subjects drinking> 21 units/week;
7. A history of metabolic or autoimmune liver diseases or viral hepatitis diseases;
8. A history of medullary thyroid carcinoma, multiple endocrine neoplasia 2 or family history;
9. Congestive heart failure (NYHA grade Ⅲ - Ⅳ grade);
10. Severe gastrointestinal diseases;
11. Other serious concomitant diseases;
12. Pregnant or planning pregnancy;
13. The researchers believe that the subjects with proliferative retinopathy or macular degeneration need urgentl treatment;
14. Subjects are using unknown ingredients or non herbal medicine preparations or local medicine, researchers believe that during the test the dose of traditional Chinese medicines can not be adjusted or disabled.
Endpoints (11)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
3 endpointsBody composition
Time frame:-7±3days; 168±3days
change from baseline, improvement
Weight
Time frame:14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days
Body weight, absolute change (kg)
change from baseline, improvement
WC
Time frame:14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
4 endpointsPlasma glucose in standard meal tolerance test
Time frame:-7±3days; 168±3days
Postprandial glucose
descriptive, improvement
Plasma insulin in standard meal tolerance test
Time frame:-7±3days; 168±3days
concentration, descriptive
Glucose control
Time frame:14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
HbA1c
Time frame:-7±3days; 84±3days; 168±3days
HbA1c, change
change from baseline, improvement
LOINC 4548-4
MASH / liver
2 endpointsIntrahepatic fat
Time frame:-7±3days; 168±3days
Liver fat content, change
change from baseline, improvement
Liver function
Time frame:-7±3days; 28±3days; 84±3days; 168±3days
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointLipid
Time frame:-7±3days; 28±3days; 84±3days; 168±3days
change from baseline, improvement
Safety / tolerability / PK
1 endpointNumber of Participants with gliclazide, liraglutide or metformin adverse events as a measure of safety and tolerability
Time frame:-7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days
Treatment-emergent AEs (any)
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.