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Trial · Interventional

CompletedPhase 4Registry data

Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes

Short name LIRAFLAME

Overview

Status
Completed
Phase
Phase 4
Enrollment
102 participants (actual)
Sponsor
Steno Diabetes Center Copenhagen · Other
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
26 Oct 2017
Primary completion
16 Aug 2019
Completion
16 Aug 2019
First posted
28 Feb 2018
Last update posted
11 Jun 2020
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 4

    LIRAFLAME

    NCT03449654

    26 Oct 2017 to 16 Aug 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The objective of this study is to evaluate the mechanism behind the anti-atherogenic effects of liraglutide. In a randomized, placebo-controlled, double-blind, parallel trial we will included 100 patients with type 2 diabetes. Patients will be randomized 1:1 to an active treatment period of 26 weeks or placebo for 26 weeks. The primary endpoint is change from baseline to week 26 in vascular inflammation, assessed by Flour Deoxy Glucose (FDG)-Positron Emission Tomography/Computed Tomography (PET/CT)

Interventions

  • LiraglutideDrug
  • Placebo (for liraglutide)Drug

Arms2

  • Other

    Liraglutide

  • Other

    placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in vascular inflammation

    Time frame · baseline to week 26

    Registry description

    Change in vascular inflammation assessed by FDG PET/CT

Secondary outcomes(4)
  1. Change in Endothelial dysfunction

    Time frame · baseline to week 26

    Registry description

    Change in endothelial dysfunction assessed with endo-PAT

  2. Change in Endothelial dysfunction

    Time frame · baseline to week 13 and 26

    Registry description

    Change in endothelial dysfunction, assessed as sublingual glycocalyx measurement

  3. Coronary artery calcium score

    Time frame · baseline to week 26

    Registry description

    Change coronary artery calcium score (absolute values)

  4. Carotid intima media thickness

    Time frame · baseline to week 26

    Registry description

    Change in carotid intima media thickness measured by ultrasound

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2021

3 results

Effect of Liraglutide on Arterial Inflammation Assessed as [18F]FDG Uptake in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial.

Ripa et al. 2021Circulation. Cardiovascular imagingcited by 48

PMID 34187185PMC8300846DOI 10.1161/circimaging.120.012174PUB-34187185

Free to read · publisher termsCC BY-NC-ND3 results

Indexing hint: Randomized controlled trial · 2021

8 results

Ceramides and phospholipids are downregulated with liraglutide treatment: results from the LiraFlame randomized controlled trial.

Zobel et al. 2021BMJ open diabetes research & carecited by 29

PMID 34518158PMC8451300DOI 10.1136/bmjdrc-2021-002395PUB-34518158

Free to read · publisher termsCC BY-NC8 results

More studies

2 studies on this page

PubMed tag: none · 2023

Ceramides are decreased after liraglutide treatment in people with type 2 diabetes: a post hoc analysis of two randomized clinical trials.

Wretlind et al. 2023Lipids in health and diseasecited by 15

PMID 37752566PMC10521385DOI 10.1186/s12944-023-01922-zPUB-37752566

CC BY
Download PDF

PubMed tag: none · 2022

Liraglutide Lowers Palmitoleate Levels in Type 2 Diabetes. A Post Hoc Analysis of the LIRAFLAME Randomized Placebo-Controlled Trial.

Wretlind et al. 2022Frontiers in clinical diabetes and healthcarecited by 4

PMID 36992761PMC10012104DOI 10.3389/fcdhc.2022.856485PUB-36992761

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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