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LIRAFLAME

CompletedPhase 4

Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes

Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes: A Randomized, Placebo-controlled, Double-blind, Parallel Clinical PET/CT Trial The Liraflame Trial

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

102

actual

Study population

Type 2 diabetes

Key I/E criterion

eGFR ≥30

Primary endpoint

Vascular inflammation

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 IDNCT03449654
Org study IDH-16044546

Timeline

Milestones

Study start2017-10-26actual
Study first posted2018-02-28actual
Primary completion2019-08-16actual
Study completion2019-08-16actual
Last update posted2020-06-11actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Given written informed consent

2. Male or female patients >50 years with type 2 diabetes (WHO criteria)

3. HbA1c ≥ 48 mmol/mol (6.5 %)

4. eGFR ≥ 30 ml/min/1.73 m2 (estimated by CKD-epi formula)

5. Stable glucose-lowering medication (excluding oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon like peptide-1 agonists and other agents, which in the investigator's opinion could interfere with the effect of liraglutide)for at least 4 weeks before the baseline PET/CT

6. Stable/no treatment of hypercholesterolemia 4 weeks before baseline PET/CT

7. Must be able to communicate with the investigator and understand informed consent.

Exclusion criteria

1. Type 1 diabetes mellitus

2. Chronic pancreatitis / previous acute pancreatitis

3. Known or suspected hypersensitivity to trial product(s) or related products

4. Treatment 90 days prior to screening with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon like peptide-1 agonists and other agents, which in the investigator's opinion could interfere with the effect of liraglutide

5. Cancer or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial

6. Clinical signs of diabetic gastroparesis

7. Previous bowel resection

8. Impaired liver function (transaminases > two times upper reference levels)

9. Inflammatory bowel disease

10. Weight >150 kg

11. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods

12. Known or suspected abuse of alcohol or narcotics

13. Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2

Endpoints (6)

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

Cardiometabolic biomarkers
5
Other clinical outcomes
1

Cardiometabolic biomarkers

5 endpoints
Primary/protocol endpoint

Change in vascular inflammation

Time frame:baseline to week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in Endothelial dysfunction

Time frame:baseline to week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in Endothelial dysfunction

Time frame:baseline to week 13 and 26

change from baseline, improvement

Secondary/protocol endpoint

Coronary artery calcium score

Time frame:baseline to week 26

change from baseline, improvement

Secondary/protocol endpoint

Carotid intima media thickness

Time frame:baseline to week 26

change from baseline, improvement

Other clinical outcomes

1 endpoint
Other/protocol endpoint

Autonomic nervous system function

Time frame:baseline to week 26

change from baseline, improvement

Publications (4)

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.