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MAGNA VICTORIA
Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus and South Asian Descent
Sponsor study identifier
interventional
51
1 country
1
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 9, 2018
Actual (reported)Study Completion
March 9, 2018
Actual (reported)Among South Asians, in comparison to Western Europeans, there is an increased risk of type 2 diabetes mellitus (DM2) and DM2-related cardiovascular disease. The effect of Liraglutide (Victoza®) on cardiovascular function is therefore investigated in the DM2 patient group of South Asian descent specifically. Liraglutide is a new widely prescribed therapeutic agent for DM2 patients. It is a Glucagon Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood pressure and body weight. The disadvantageous metabolic phenotype as seen in South Asians includes a relatively large total fat mass, with predominately visceral relative to subcutaneous adipose tissue and lower brown adipose tissue volume and activity, accompanied by increased lipid levels. The key elements in the mechanism of action of Liraglutide seem to correspond to the differences in metabolic profile between South Asians and Western Europeans. Diastolic dysfunction, an early finding of cardiovascular disease in DM2 and obesity and an independent predictor of mortality, has been shown to be associated with the amount of triglyceride accumulation in the heart and liver. The investigators hypothesize that Liraglutide has direct advantageous cardiovascular effects and reduces triglyceride accumulation in end-organs, specifically for DM2 patients of South Asian descent.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 9, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 18, 2016
Actual (reported)January 21, 2016
Actual (reported)March 9, 2018
Actual (reported)March 9, 2018
Actual (reported)Stroke volume
Change from baseline in ml: difference between groups
0 and 26 weeks
Ejection Fraction
Change from baseline in percentage: difference between groups
0 and 26 weeks
Cardiac output
Change from baseline in L/min: difference between groups
0 and 26 weeks
Cardiac index
Liraglutide: Solution for subcutaneous injection 6 mg/ml; Flexpen 3 ml. Dose: s.c. 0,6 mg (0,1 mL) once daily. After 1 week, the dose will be increased to 1,2 mg (0,2 mL) once daily. If tolerated, after 1 week, dose will be increased to 1.8 mg (0,3 mL) once daily. In case of a hypoglycaemic episode, the dosage of oral blood glucose lowering medicaments will be adjusted first. If hypoglycaemia persists, Liraglutide / Liraglutide placebo will be adjusted on the basis of clinical parameters. Duration: 26 weeks
Liraglutide placebo: Solution for injection; Flexpen 3 ml. Dose: same as Liraglutide Duration: 26 weeks
Drug: Liraglutide Preparation and labelling of Investigational Medicinal Product: Liraglutide will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk. Drug accountability: Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial.
Leiden University Medical Center
Leiden, Albinusdreef 2, 2333 ZA, Netherlands
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Hoekx CA, Martinez-Tellez B, Straat ME, Bizino MB, van Eyk HJ, Lamb HJ, Smit JWA, Jazet IM, Nahon KJ, Janssen LGM, Rensen PCN, Boon MR. Circulating FGF21 is lower in South Asians compared with Europids with type 2 diabetes mellitus. Endocr Connect. 2025 Jan 6;14(2):e240362. doi: 10.1530/EC-24-0362. Print 2025 Feb 1.
Elisabeth HM Paiman, MD
Leiden University Medical Center
Huub J van Eyk, MD
Leiden University Medical Center
Hildo J Lamb, MD PhD
Leiden University Medical Center
Jan W Smit, MD PhD
University Nijmegen Medical Centre
51 participants (actual enrollment reported by the registry).
First Submitted
January 18, 2016
First Posted
January 21, 2016
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Change from baseline in L/min/m2: difference between groups
0 and 26 weeks
Peak ejection rate
Change from baseline in ml end-diastolic volume/sec: difference between groups
0 and 26 weeks
Early peak filling rate
Change from baseline in ml end-diastolic volume/sec: difference between groups
0 and 26 weeks
Early deceleration peak
Change from baseline in ml/sec: difference between groups
0 and 26 weeks
Atrial peak filling rate
Change from baseline in ml/sec: difference between groups
0 and 26 weeks
Early deceleration peak / Atrial peak filling rate (E/A ratio)
Change from baseline of the ratio: difference between groups
0 and 26 weeks
Peak mitral annulus longitudinal motion
Change from baseline in cm/sec: difference between groups
0 and 26 weeks
Left ventricular filling pressure (= early peak filling rate / peak mitral annulus longitudinal motion)
Change from baseline in mmHg: difference between groups
0 and 26 weeks
Aorta vessel wall imaging
0 and 26 weeks
Carotid vessel wall imaging
0 and 26 weeks
Adipose tissue distribution
0 and 26 weeks
Total body fat
0 and 26 weeks
Epicardial fat volume
0 and 26 weeks
Anthropometric measurements
0, 4, 8, 12, 16, 20, 26 weeks
Waist / hip ratio
0, 4, 8, 12, 16, 20, 26 weeks
Systolic blood pressure
0, 4, 8, 12, 16, 20, 26 weeks
Drug: Liraglutide - Placebo Preparation and labelling of Investigational Medicinal Product: Liraglutide - Placebo will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk. Drug accountability: Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Straat ME, Martinez-Tellez B, van Eyk HJ, Bizino MB, van Veen S, Vianello E, Stienstra R, Ottenhoff THM, Lamb HJ, Smit JWA, Jazet IM, Rensen PCN, Boon MR. Differences in Inflammatory Pathways Between Dutch South Asians vs Dutch Europids With Type 2 Diabetes. J Clin Endocrinol Metab. 2023 Mar 10;108(4):931-940. doi: 10.1210/clinem/dgac598.
Dekkers IA, Bizino MB, Paiman EHM, Smit JW, Jazet IM, de Vries APJ, Lamb HJ. The Effect of Glycemic Control on Renal Triglyceride Content Assessed by Proton Spectroscopy in Patients With Type 2 Diabetes Mellitus: A Single-Center Parallel-Group Trial. J Ren Nutr. 2021 Nov;31(6):611-619. doi: 10.1053/j.jrn.2020.09.006. Epub 2020 Dec 5.
van Eyk HJ, Paiman EHM, Bizino MB, de Heer P, Geelhoed-Duijvestijn PH, Kharagjitsingh AV, Smit JWA, Lamb HJ, Rensen PCN, Jazet IM. A double-blind, placebo-controlled, randomised trial to assess the effect of liraglutide on ectopic fat accumulation in South Asian type 2 diabetes patients. Cardiovasc Diabetol. 2019 Jul 9;18(1):87. doi: 10.1186/s12933-019-0890-5.
Ingrid M Jazet, MD PhD
Leiden University Medical Center
Albert M de Roos, MD PhD
Leiden University Medical Center
Primary Completion
March 9, 2018
Actual (reported)Study Completion
March 9, 2018
Actual (reported)Last Updated
March 21, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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