MAGNA VICTORIA

CompletedPhase 4

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

Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus

Lead sponsor

Leiden University Medical Center

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7-10%•eGFR ≥60

Primary endpoints

•Stroke volume•Ejection Fraction•Cardiac output

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

NCT IDNCT01761318

Org study ID379

Secondary ID2012-001623-12

Timeline

Milestones

Study first posted2013-01-04estimated

Last update posted2016-05-05estimated

Study start2013-11 (month precision)

Primary completion2016-03actual (month precision)

Study completion2016-03actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age69 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent

•Age > 18 years and < 70 years

•BMI > 25 kg/m2

•DM2 treated with metformin, metformin + SU derivative, metformin + SU derivative + insulin, or metformin + insulin for at least 3 months in the maximum tolerable dosage

•HbA1c ≥7% and ≤ 10.0 %

•EGFR > 60 ml/min

•Normal sitting blood pressure < 150/85 mm Hg and stable for at least one month

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

•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

•History or presence of cardiovascular disease

•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

Endpoints (48)

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

Other (unclassified)

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

MASH / liver

Renal / kidney

Heart failure

Safety / tolerability / PK

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Adipose tissue distribution

Time frame:0 and 26 weeks

ratio, improvement

Secondary/protocol endpoint

Total body fat

Time frame:0 and 26 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Epicardial fat volume

Time frame:0 and 26 weeks

change from baseline, improvement

Other/protocol endpoint

Anthropometric measurements

Time frame:0, 4, 8, 12, 16, 20, 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Waist / hip ratio

Time frame:0, 4, 8, 12, 16, 20, 26 weeks

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

HBA1C

Time frame:0,8, 12, 16 and 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting blood glucose level

Time frame:0, 4, 8, 12, 16, 20, 26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

Fasting insulin level

Time frame:0 and 26 weeks

change from baseline, improvement

Other/protocol endpoint

Glucagon

Time frame:0 and 26 weeks

change from baseline, improvement

Other/protocol endpoint

QUICKI

Time frame:0 and 26 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Insulin dose

Time frame:0 and 26 weeks

change from baseline, improvement

MASH / liver

2 endpoints

Secondary/protocol endpoint

Magnetic Resonance Spectroscopy of the liver

Time frame:0 and 26 weeks

Liver fat content, change

change from baseline, improvement

Other/protocol endpoint

Liver function tests (ALT, AST, AF, GGT)

Time frame:0, 4, 12 and 26 weeks

change from baseline, improvement

Heart failure

1 endpoint

Primary/protocol endpoint

Ejection Fraction

Time frame:0 and 26 weeks

change from baseline, improvement

Renal / kidney

2 endpoints

Secondary/protocol endpoint/low confidence

Magnetic Resonance Spectroscopy of the kidney

Time frame:0 and 26 weeks

percent change from baseline, improvement

Other/protocol endpoint

Albuminuria

Time frame:0 and 26 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Aorta and carotid vessel wall imaging

Time frame:0 and 26 weeks

change from baseline, improvement

Other/protocol endpoint

Systolic blood pressure

Time frame:0, 4, 8, 12, 16, 20, 26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Diastolic blood pressure

Time frame:0, 4, 8, 12, 16, 20, 26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other/protocol endpoint

Leptin

Time frame:0 and 26 weeks

Leptin, change

change from baseline, improvement

Other/protocol endpoint

Adiponectin

Time frame:0 and 26 weeks

Adiponectin, change

change from baseline, improvement

Other/protocol endpoint

CETP

Time frame:0, 4, 12 and 26 weeks

change from baseline, improvement

Other/protocol endpoint

High Sensitive C Reactive Protein

Time frame:0, 4, 12 and 26 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other/protocol endpoint

Free Fatty Acids

Time frame:0, 4, 12 and 26 weeks

Free fatty acids, change

change from baseline, improvement

Other/protocol endpoint

Cholesterol level (total, HDL and LDL)

Time frame:0, 4, 12 and 26 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Other/protocol endpoint

Triglycerides

Time frame:0, 4 , 12 and 26 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

Hypoglycaemic episodes

Time frame:Between week 0 and 26

Documented hypoglycemia

event count, event

Other (unclassified)

21 endpoints

Primary/protocol endpoint/low confidence

Stroke volume

Time frame:0 and 26 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Cardiac output

Time frame:0 and 26 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Cardiac index

Time frame:0 and 26 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Peak ejection rate

Time frame:0 and 26 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Early peak filling rate

Time frame:0 and 26 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Early deceleration peak

Time frame:0 and 26 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Atrial peak filling rate

Time frame:0 and 26 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Early deceleration peak / Atrial peak filling rate (E/A ratio)

Time frame:0 and 26 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Peak mitral annulus longitudinal motion

Time frame:0 and 26 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Left ventricular filling pressure (= early peak filling rate / peak mitral annulus longitudinal motion)

Time frame:0 and 26 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Aorta and carotid vessel wall imaging

Time frame:0 and 26 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Aorta and carotid vessel wall imaging

Time frame:0 and 26 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Aorta and carotid vessel wall imaging

Time frame:0 and 26 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Aorta and carotid vessel wall imaging

Time frame:0 and 26 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Magnetic Resonance Spectroscopy of the heart

Time frame:0 and 26 weeks

percent change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Myocardial T1 - mapping

Time frame:0 and 26 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Resting Energy Expenditure

Time frame:0, 4, 12, 26 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Immunological analysis

Time frame:0, 26 weeks

descriptive

Other/protocol endpoint/low confidence

Immunological analysis

Time frame:0, 26 weeks

descriptive

Other/protocol endpoint/low confidence

Immunological analysis

Time frame:0 and 26 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Metabolomics

Time frame:0 and 26 weeks

change from baseline, descriptive

Publications (51)

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

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Circulating FGF21 is lower in South Asians compared with Europids with type 2 diabetes mellitus.
Endocrine connections2025 Feb 1PMID39641307doi:10.1530/EC-24-0362via clinicaltrials gov reference derived + pubmed nct search
Differences in Inflammatory Pathways Between Dutch South Asians vs Dutch Europids With Type 2 Diabetes.
The Journal of clinical endocrinology and metabolism2023 Mar 10PMID36262060doi:10.1210/clinem/dgac598via clinicaltrials gov reference derived + pubmed nct search
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.
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation2021 Nov (month)PMID33293204doi:10.1053/j.jrn.2020.09.006via clinicaltrials gov reference derived + pubmed nct search
Liraglutide decreases energy expenditure and does not affect the fat fraction of supraclavicular brown adipose tissue in patients with type 2 diabetes.
Nutrition, metabolism, and cardiovascular diseases : NMCD2020 Apr 12PMID32127340doi:10.1016/j.numecd.2019.12.005via clinicaltrials gov reference derived + pubmed nct search
Placebo-controlled randomised trial with liraglutide on magnetic resonance endpoints in individuals with type 2 diabetes: a pre-specified secondary study on ectopic fat accumulation.
Diabetologia2020 Jan (month)PMID31690988doi:10.1007/s00125-019-05021-6via clinicaltrials gov reference derived + pubmed nct search
Hepatic triglyceride content does not affect circulating CETP: lessons from a liraglutide intervention trial and a population-based cohort.
Scientific reports2019 Jul 10PMID31292457doi:10.1038/s41598-019-45593-2via clinicaltrials gov reference derived + pubmed nct search
Effect of liraglutide on cardiac function in patients with type 2 diabetes mellitus: randomized placebo-controlled trial.
Cardiovascular diabetology2019 Apr 30PMID31039778doi:10.1186/s12933-019-0857-6via clinicaltrials gov reference derived + pubmed nct search
Body fat distribution and risk of cardiovascular disease: an update.
Circulation2012 Sep 4PMID22949540doi:10.1161/CIRCULATIONAHA.111.067264via CT.gov background
MR imaging evaluation of cardiovascular risk in metabolic syndrome.
Radiology2012 Jul (month)PMID22723560doi:10.1148/radiol.12110772via CT.gov background
Ventricular assist device implantation corrects myocardial lipotoxicity, reverses insulin resistance, and normalizes cardiac metabolism in patients with advanced heart failure.
Circulation2012 Jun 12PMID22586279doi:10.1161/CIRCULATIONAHA.111.060889via CT.gov background
Cause-specific mortality in diabetes: recent changes in trend mortality.
European journal of preventive cardiology2012 Jun (month)PMID22991697doi:10.1177/1741826711409324via CT.gov background
Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies.
Lancet (London, England)2010 Jun 26PMID20609967doi:10.1016/S0140-6736(10)60484-9via CT.gov background
Pioglitazone compared with metformin increases pericardial fat volume in patients with type 2 diabetes mellitus.
The Journal of clinical endocrinology and metabolism2010 Jan (month)PMID19915017doi:10.1210/jc.2009-1441via CT.gov background
Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue.
Diabetes, obesity & metabolism2009 Dec (month)PMID19930006doi:10.1111/j.1463-1326.2009.01158.xvia CT.gov background
The cardioprotective and inotropic components of the postconditioning effects of GLP-1 and GLP-1(9-36)a in an isolated rat heart.
Pharmacological research2009 Nov (month)PMID19540343doi:10.1016/j.phrs.2009.06.004via CT.gov background
Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity.
Circulation2009 Oct 20PMID19805654doi:10.1161/CIRCULATIONAHA.109.192644via CT.gov background
Altered myocardial substrate metabolism and decreased diastolic function in nonischemic human diabetic cardiomyopathy: studies with cardiac positron emission tomography and magnetic resonance imaging.
Journal of the American College of Cardiology2009 Oct 13PMID19815124doi:10.1016/j.jacc.2009.04.074via CT.gov background
Pioglitazone improves cardiac function and alters myocardial substrate metabolism without affecting cardiac triglyceride accumulation and high-energy phosphate metabolism in patients with well-controlled type 2 diabetes mellitus.
Circulation2009 Apr 21PMID19349323doi:10.1161/CIRCULATIONAHA.108.803916via CT.gov background
Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU).
Diabetic medicine : a journal of the British Diabetic Association2009 Mar (month)PMID19317822doi:10.1111/j.1464-5491.2009.02666.xvia CT.gov background
Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury.
Journal of the American College of Cardiology2009 Feb 10PMID19195607doi:10.1016/j.jacc.2008.10.033via CT.gov background
Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial.
Lancet (London, England)2009 Feb 7PMID18819705doi:10.1016/S0140-6736(08)61246-5via CT.gov background
GLP-1 and related peptides cause concentration-dependent relaxation of rat aorta through a pathway involving KATP and cAMP.
Archives of biochemistry and biophysics2008 Oct 15PMID18708025doi:10.1016/j.abb.2008.08.001via CT.gov background
Prolonged caloric restriction in obese patients with type 2 diabetes mellitus decreases myocardial triglyceride content and improves myocardial function.
Journal of the American College of Cardiology2008 Sep 16PMID18786482doi:10.1016/j.jacc.2008.04.068via CT.gov background
Short-term flexibility of myocardial triglycerides and diastolic function in patients with type 2 diabetes mellitus.
American journal of physiology. Endocrinology and metabolism2008 Sep (month)PMID18628354doi:10.1152/ajpendo.90413.2008via CT.gov background
Effects of short-term high-fat, high-energy diet on hepatic and myocardial triglyceride content in healthy men.
The Journal of clinical endocrinology and metabolism2008 Jul (month)PMID18430773doi:10.1210/jc.2007-2524via CT.gov background
Cardioprotective and vasodilatory actions of glucagon-like peptide 1 receptor are mediated through both glucagon-like peptide 1 receptor-dependent and -independent pathways.
Circulation2008 May 6PMID18427132doi:10.1161/CIRCULATIONAHA.107.739938via CT.gov background
Protective effects of GLP-1 analogues exendin-4 and GLP-1(9-36) amide against ischemia-reperfusion injury in rat heart.
Regulatory peptides2008 Feb 7PMID17976835doi:10.1016/j.regpep.2007.10.001via CT.gov background
Progressive caloric restriction induces dose-dependent changes in myocardial triglyceride content and diastolic function in healthy men.
The Journal of clinical endocrinology and metabolism2008 Feb (month)PMID18029455doi:10.1210/jc.2007-2015via CT.gov background
Metabolic imaging of myocardial triglyceride content: reproducibility of 1H MR spectroscopy with respiratory navigator gating in volunteers.
Radiology2007 Oct (month)PMID17885193doi:10.1148/radiol.2451061904via CT.gov background
Cardiac steatosis in diabetes mellitus: a 1H-magnetic resonance spectroscopy study.
Circulation2007 Sep 4PMID17698735doi:10.1161/CIRCULATIONAHA.106.645614via CT.gov background
Effect of glucagon-like peptide-1 (GLP-1) on glycemic control and left ventricular function in patients undergoing coronary artery bypass grafting.
The American journal of cardiology2007 Sep 1PMID17719327doi:10.1016/j.amjcard.2007.05.022via CT.gov background
Glucagon-like peptide-1 infusion improves left ventricular ejection fraction and functional status in patients with chronic heart failure.
Journal of cardiac failure2006 Dec (month)PMID17174230doi:10.1016/j.cardfail.2006.08.211via CT.gov background
Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes.
Diabetes, obesity & metabolism2006 Jul (month)PMID16776751doi:10.1111/j.1463-1326.2006.00602.xvia CT.gov background
Exendin-4, a glucagon-like protein-1 (GLP-1) receptor agonist, reverses hepatic steatosis in ob/ob mice.
Hepatology (Baltimore, Md.)2006 Jan (month)PMID16374859doi:10.1002/hep.21006via CT.gov background
The burden of mortality attributable to diabetes: realistic estimates for the year 2000.
Diabetes care2005 Sep (month)PMID16123478doi:10.2337/diacare.28.9.2130via CT.gov background
Glucagon-like peptide-1 relaxes rat conduit arteries via an endothelium-independent mechanism.
Regulatory peptides2005 Feb 15PMID15582729doi:10.1016/j.regpep.2004.08.024via CT.gov background
Hepatic triglyceride content and its relation to body adiposity: a magnetic resonance imaging and proton magnetic resonance spectroscopy study.
Gut2005 Jan (month)PMID15591516doi:10.1136/gut.2003.036566via CT.gov background
Glucagon like peptide-1 is protective against myocardial ischemia/reperfusion injury when given either as a preconditioning mimetic or at reperfusion in an isolated rat heart model.
Cardiovascular drugs and therapy2005 Jan (month)PMID15883751doi:10.1007/s10557-005-6892-4via CT.gov background
Effects of glucagon-like peptide-1 on endothelial function in type 2 diabetes patients with stable coronary artery disease.
American journal of physiology. Endocrinology and metabolism2004 Dec (month)PMID15353407doi:10.1152/ajpendo.00237.2004via CT.gov background
Recombinant glucagon-like peptide-1 increases myocardial glucose uptake and improves left ventricular performance in conscious dogs with pacing-induced dilated cardiomyopathy.
Circulation2004 Aug 24PMID15313949doi:10.1161/01.CIR.0000139339.85840.DDvia CT.gov background
Intramyocellular lipids and insulin resistance.
Diabetes, obesity & metabolism2004 Jul (month)PMID15171747doi:10.1111/j.1462-8902.2004.00339.xvia CT.gov background
Global prevalence of diabetes: estimates for the year 2000 and projections for 2030.
Diabetes care2004 May (month)PMID15111519doi:10.2337/diacare.27.5.1047via CT.gov background
Effects of glucagon-like peptide-1 in patients with acute myocardial infarction and left ventricular dysfunction after successful reperfusion.
Circulation2004 Mar 2PMID14981009doi:10.1161/01.CIR.0000120505.91348.58via CT.gov background
Diastolic dysfunction is associated with altered myocardial metabolism in asymptomatic normotensive patients with well-controlled type 2 diabetes mellitus.
Journal of the American College of Cardiology2003 Jul 16PMID12875772doi:10.1016/s0735-1097(03)00625-9via CT.gov background
Lipotoxicity: when tissues overeat.
Current opinion in lipidology2003 Jun (month)PMID12840659doi:10.1097/00041433-200306000-00008via CT.gov background
Mitral ratio of peak early to late diastolic filling velocity as a predictor of mortality in middle-aged and elderly adults: the Strong Heart Study.
Circulation2002 Apr 23PMID11997279doi:10.1161/01.cir.0000015076.37047.d9via CT.gov background
Effect of 6-week course of glucagon-like peptide 1 on glycaemic control, insulin sensitivity, and beta-cell function in type 2 diabetes: a parallel-group study.
Lancet (London, England)2002 Mar 9PMID11897280doi:10.1016/S0140-6736(02)07952-7via CT.gov background
Dietary treatment and long-term weight loss and maintenance in type 2 diabetes.
Obesity research2001 Nov (month)PMID11707564doi:10.1038/oby.2001.141via CT.gov background
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group.
Lancet (London, England)1998 Sep 12PMID9742976via CT.gov background
Early abnormalities of cardiac function in non-insulin-dependent diabetes mellitus and impaired glucose tolerance.
The American journal of cardiology1995 Dec 1PMID7484905doi:10.1016/s0002-9149(99)80330-0via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.