Trial · Interventional

CompletedPhase 4Registry data

Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients of South Asian Descent

Short name MAGNA VICTORIA

NCTNCT02660047Other id2012-001623-12

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 51 participants (actual)
Sponsor: Leiden University Medical Center · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Netherlands
Start: Aug 2015
Primary completion: 9 Mar 2018
Completion: 9 Mar 2018
First posted: 21 Jan 2016 (estimated)
Last update posted: 21 Mar 2018
Conditions: Diabetes Mellitus Type 2 · Metabolic Syndrome · Cardiovascular Disease · Diastolic Dysfunction · Fatty Liver

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20152016201720182019

Ph 4
MAGNA VICTORIA
NCT02660047
Aug 2015 to 9 Mar 2018

Registry summary

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

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.

Interventions

LiraglutideDrug
Liraglutide - PlaceboDrug

Arms2

Active comparator
Liraglutide
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
Placebo comparator
Liraglutide - Placebo
Liraglutide placebo: Solution for injection; Flexpen 3 ml. Dose: same as Liraglutide Duration: 26 weeks

Primary outcomes11

Outcomes the sponsor listed as primary.

Stroke volume
Time frame · 0 and 26 weeks
Registry description
Change from baseline in ml: difference between groups
Ejection Fraction
Time frame · 0 and 26 weeks
Registry description
Change from baseline in percentage: difference between groups
Cardiac output
Time frame · 0 and 26 weeks
Registry description
Change from baseline in L/min: difference between groups
Cardiac index
Time frame · 0 and 26 weeks
Registry description
Change from baseline in L/min/m2: difference between groups
Peak ejection rate
Time frame · 0 and 26 weeks
Registry description
Change from baseline in ml end-diastolic volume/sec: difference between groups
Early peak filling rate
Time frame · 0 and 26 weeks
Registry description
Change from baseline in ml end-diastolic volume/sec: difference between groups
Early deceleration peak
Time frame · 0 and 26 weeks
Registry description
Change from baseline in ml/sec: difference between groups
Atrial peak filling rate
Time frame · 0 and 26 weeks
Registry description
Change from baseline in ml/sec: difference between groups
Early deceleration peak / Atrial peak filling rate (E/A ratio)
Time frame · 0 and 26 weeks
Registry description
Change from baseline of the ratio: difference between groups
Peak mitral annulus longitudinal motion
Time frame · 0 and 26 weeks
Registry description
Change from baseline in cm/sec: difference between groups
Left ventricular filling pressure (= early peak filling rate / peak mitral annulus longitudinal motion)
Time frame · 0 and 26 weeks
Registry description
Change from baseline in mmHg: difference between groups

Secondary outcomes(12)

Aorta vessel wall imaging
Time frame · 0 and 26 weeks
Registry description
Change from baseline of vascular distensibility (pulse wave velocity): difference between groups
Carotid vessel wall imaging
Time frame · 0 and 26 weeks
Registry description
Change from baseline of average vessel wall thickness in mm: difference between groups
Adipose tissue distribution
Time frame · 0 and 26 weeks
Registry description
Change from baseline of the ratio subcutaneous fat / visceral abdominal fat: difference between groups
Total body fat
Time frame · 0 and 26 weeks
Registry description
Change from baseline of total fat volume in ml: difference between groups
Epicardial fat volume
Time frame · 0 and 26 weeks
Registry description
Change from baseline in cm3: difference between groups
Magnetic Resonance Spectroscopy of the heart
Time frame · 0 and 26 weeks
Registry description
Change from baseline in percentage: difference between groups
Magnetic Resonance Spectroscopy of the liver
Time frame · 0 and 26 weeks
Registry description
Change from baseline in percentage: difference between groups
Magnetic Resonance Spectroscopy of the kidney
Time frame · 0 and 26 weeks
Registry description
Change from baseline in percentage: difference between groups
HBA1C
Time frame · Time Frame: 0,8, 12, 16 and 26 weeks
Registry description
Measurements will be used to guide therapeutic management The outcome measure glycemic control will be based on the average HBA1C level of all measurements and regards: difference between groups.
Fasting blood glucose level
Time frame · 0, 4, 8, 12, 16, 20, 26 weeks
Registry description
Fasting blood glucose levels will be used to guide therapeutic management and for safety reasons. Outcome measure: the difference between groups of the average of all measurements.
Myocardial T1 - mapping
Time frame · 0 and 26 weeks
Registry description
Change from baseline of myocardial T1 - values before and after contrast: difference between groups
Brown adipose tissue
Time frame · 0 and 26 weeks
Registry description
Change from baseline of brown adipose tissue volume in cm3: difference between groups

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

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results

Source link See results (15)

Indexing hint: Randomized controlled trial · 2021

1 result

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.

Dekkers et al. 2021Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundationcited by 15

PMID 33293204DOI 10.1053/j.jrn.2020.09.006PUB-33293204

Full text at the publisher1 result

Publisher page See results (1)

Indexing hint: Randomized controlled trial · 2019

6 results

A double-blind, placebo-controlled, randomised trial to assess the effect of liraglutide on ectopic fat accumulation in South Asian type 2 diabetes patients.

van Eyk et al. 2019Cardiovascular diabetologycited by 70

PMID 31288820PMC6615254DOI 10.1186/s12933-019-0890-5PUB-31288820

CC BY6 results

Download PDF See results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedHoekx 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. PMID 39641307
DerivedStraat 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. PMID 36262060

Eligibility

Who could join, as posted.

Sex: All
Age: from 19 Years up to 74 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Informed consent * Age \> 18 years and \< 75 years * BMI \> 23 kg/m2 * DM2 treated with metformin and/or SU derivative and/or insulin for at least 3 months in stable dosage * HbA1c ≥ 6.5% and ≤ 11.0% (≥ 47.5 mmol/mol and ≤ 97.4 mmol/mol) * EGFR \> 30 ml/min * Ethnicity: South Asian descent (i.e. Hindustani Surinamese), based on self-identified ethnicity and self-reported origin of the mother, the father and the mother's and father's ancestors. Both parents and the mother's and father's ancestors should be South Asian for inclusion. Exclusion Criteria: * Use of thiazolidinediones (TZD), GLP-1 analogues, DPP-IV inhibitors, fibrates, prednisone, cytostatic or antiretroviral therapy within 6 months prior to the study * Uncontrolled treated or untreated hypertension (systolic blood pressue ≥ 180 mmHg and/or diastolic blood pressue ≥ 110 mmHg) * Acute coronary or cerebrovascular event within 30 days prior to study * Congestive heart failure NYHA III-IV * Hereditary lipoprotein disease * Psychiatric disorders and / or use of antipsychotic or antidepressant drugs at present or in the past * Hepatic disease (AST/ALT \> 2 times reference values) * Endocrine disease other than diabetes mellitus type 2 * Any significant chronic disease (e.g. inflammatory bowel disease) * Any significant abnormal laboratory results found during the medical screening procedure * Gastrointestinal surgery (e.g. gastric bypass) * Pregnant woman or a woman who is breast-feeding * Female of child-bearing potential intending to become pregnant or is not using adequate contraceptive methods while sexually active * Allergy to intravenous contrast * Known or suspected hypersensitivity to trial products or related products * Chronic pancreatitis or previous acute pancreatitis * Personal history or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia type 2 * Claustrophobia * Metal implants or other contraindications for MRI * Recent participation in other research projects within the last 3 months or participation in 2 or more projects in one year

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