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LIRAFLAME
CompletedPhase 4Effect 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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsChange in vascular inflammation
Time frame:baseline to week 26
change from baseline, improvement
Change in Endothelial dysfunction
Time frame:baseline to week 26
change from baseline, improvement
Change in Endothelial dysfunction
Time frame:baseline to week 13 and 26
change from baseline, improvement
Coronary artery calcium score
Time frame:baseline to week 26
change from baseline, improvement
Carotid intima media thickness
Time frame:baseline to week 26
change from baseline, improvement
Other clinical outcomes
1 endpointAutonomic 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
- Lipids in health and disease2023 Sep 26PMID37752566doi:10.1186/s12944-023-01922-zvia clinicaltrials gov reference derived + pubmed nct search
- Frontiers in clinical diabetes and healthcare2022 (year)PMID36992761doi:10.3389/fcdhc.2022.856485via clinicaltrials gov reference derived + pubmed nct search
- BMJ open diabetes research & care2021 Sep (month)PMID34518158doi:10.1136/bmjdrc-2021-002395via clinicaltrials gov reference derived + pubmed nct search
- Circulation. Cardiovascular imaging2021 Jul (month)PMID34187185doi:10.1161/CIRCIMAGING.120.012174via clinicaltrials gov reference derived + pubmed nct search
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.