DelfaGLP-1 Atlas

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LIRAINS

CompletedPhase 2

Study of Liraglutide Versus Insulin on Liver Fat Fraction in Patients With Type 2 Diabetes

Randomized Trial of Liraglutide and Insulin Therapy on Hepatic Steatosis as Measured by MRI and MRS in Metformin-treated Patients With Type 2 Diabetes: an Open Pilot Study

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

35

actual

Study population

MASH / NAFLD / liver fibrosis, Type 2 diabetes

Key I/E criterion

•HbA1c ≥6.5%

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 IDNCT01399645
Org study IDCE09.159

Timeline

Milestones

Study first posted2011-07-22estimated
Last update posted2014-08-27estimated
Study start2011-05 (month precision)
Primary completion2014-06actual (month precision)
Study completion2014-06actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Are 18 y.o. or older at screening (first visit),
•Are ambulatory,
•Are known for type 2 diabetes with criteria of failure of metformin monotherapy, metformin-sulfonylurea, metformin-repaglinide combined therapy defined as HbA1C ≥6.5,
•Abdominal girth > 94 cm for men and > 80 cm for women,
•Understand French or English instruction,
•Able to comprehend and willingness to provide voluntary consent.

Exclusion criteria

•Have any contra-indications for MRI (such as metallic implants, pacemaker or claustrophobia),
•Have type 1 diabetes or have had episodes of ketoacidosis,
•Have any major debilitating disease including malignant disorders,
•Have had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), or severe ischemic disease,
•Patients having received insulin within 3 months prior to screening,
•Have a serum creatine above >150 mmol/L or estimated GFR < 30 mL/min,
•Women seeking pregnancy,
•Have a history of chronic liver disease other than NAFLD, including HBV and HCV infection, hemochromatosis, Wilson's disease, alpha-1-antitrypsin deficiency, autoimmune hepatitis,
•Current or previous use of oral or injectable corticosteroids,
•Have excessive alcohol intake, defined as a daily limit of 30 g (3 drinks) for men and 20 g (2 drinks) for women.

Endpoints (1)

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.

MASH / liver

1 endpoint
Primary/protocol endpoint

To determine liver fat fraction evolution induced by liraglutide and insulin

Time frame:12 weeks

Liver fat content, change

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.