A Phase 4 interventional study of Liraglutide and Placebo (for liraglutide) in Diabetes Mellitus, Type 2, sponsored by Steno Diabetes Center Copenhagen. Completed at 1 site in Denmark. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Steno Diabetes Center Copenhagen · Phase 4, Interventional, and Prevention
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)
Despite multifactorial treatment patients with type 2 diabetes are still at high risk of cardiovascular disease. The clinical LEADER trial demonstrated a reduction in cardiovascular events in patients with type 2 diabetes treated with the GLP-1 receptor agonist liraglutide and there are a number of studies indicating that liraglutide has a positive effect on the vascular phenotype. Several of the animal or ex vivo studies suggest an anti-inflammatory mechanism behind this effect. However, no in vivo human studies have been undertaken to test this hypothesis and it would be of significance to determine the precise mechanism since atherosclerosis has large prognostic impact in patients with type 2 diabetes.
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). FDG-PET/CT is currently the only clinically available technique for specific in vivo evaluation of vascular inflammation and for quantification of the effects of medical intervention on plaque inflammation. FDG-PET of arteries has been proven very reproducible and therefore has high power to show a treatment effect in a smaller group of patients.
A number of complementary methods exist that assess different steps in the atherogenesis like endothelial function (e.g. endo-PAT, glycocalyx measurement), artery wall thickening (e.g. carotid intima media thickness), or coronary atherosclerosis (e.g. coronary artery calcium score). For comparison these other methods will be included as secondary endpoints as they are generally more accessible and less expensive.
Exclusion Criteria:
Drug: Liraglutide
Drug: Placebo (for liraglutide)
Liraglutid
Placebo (for liraglutide)
Change in vascular inflammation
Change in vascular inflammation assessed by FDG PET/CT
Time frame: baseline to week 26
Change in Endothelial dysfunction
Change in endothelial dysfunction assessed with endo-PAT
Time frame: baseline to week 26
Change in Endothelial dysfunction
Change in endothelial dysfunction, assessed as sublingual glycocalyx measurement
Time frame: baseline to week 13 and 26
Coronary artery calcium score
Change coronary artery calcium score (absolute values)
Time frame: baseline to week 26
Carotid intima media thickness
Change in carotid intima media thickness measured by ultrasound
Time frame: baseline to week 26
Autonomic nervous system function
Change in cardiovascular autonomic neuropathy indices
Time frame: baseline to week 26
Plan to share: No
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Steno Diabetes Center Copenhagen