← Trials/Trial dossier/NCT03068065

CompletedPhase 4

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 20-35HbA1c 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

NCT IDNCT03068065
Org study IDChiCTR-TRC-14004660

Timeline

Milestones

Study first posted2017-03-01actual
Last update posted2017-03-01actual
Study start2014-05actual (month precision)
Primary completion2014-11actual (month precision)
Study completion2015-10actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age17 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
4
Weight & body composition
3
MASH / liver
2
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Body composition

Time frame:-7±3days; 168±3days

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Plasma glucose in standard meal tolerance test

Time frame:-7±3days; 168±3days

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Plasma insulin in standard meal tolerance test

Time frame:-7±3days; 168±3days

concentration, descriptive

Secondary/protocol endpoint

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

Secondary/protocol endpoint

HbA1c

Time frame:-7±3days; 84±3days; 168±3days

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints
Primary/protocol endpoint

Intrahepatic fat

Time frame:-7±3days; 168±3days

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Liver function

Time frame:-7±3days; 28±3days; 84±3days; 168±3days

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Lipid

Time frame:-7±3days; 28±3days; 84±3days; 168±3days

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Number 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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.