MAGNA VICTORIA

CompletedPhase 4

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

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

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 ≥23•HbA1c 6.5-11%•eGFR ≥30

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 IDNCT02660047

Org study ID2012-001623-12

Timeline

Milestones

Study first posted2016-01-21estimated

Primary completion2018-03-09actual

Study completion2018-03-09actual

Last update posted2018-03-21actual

Study start2015-08 (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age19 Years

Maximum age74 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (45)

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

Weight & body composition

Glycemic / diabetes

MASH / liver

Renal / kidney

Safety / tolerability / PK

Weight & body composition

6 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

Secondary/protocol endpoint

Brown adipose tissue

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

5 endpoints

Secondary/protocol endpoint

HBA1C

Time frame: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

QUICKI

Time frame:0 and 26 weeks

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

percent 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

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

11 endpoints

Secondary/protocol endpoint

Aorta vessel wall imaging

Time frame:0 and 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

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:Change from baseline: difference between groups

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

change from baseline, improvement

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)

18 endpoints

Primary/protocol endpoint/low confidence

Stroke volume

Time frame:0 and 26 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Ejection Fraction

Time frame:0 and 26 weeks

change from baseline, improvement

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, improvement

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, 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

change from baseline, descriptive

Other/protocol endpoint/low confidence

Immunological analysis

Time frame:0, 26 weeks

change from baseline, 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 (5)

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
A double-blind, placebo-controlled, randomised trial to assess the effect of liraglutide on ectopic fat accumulation in South Asian type 2 diabetes patients.
Cardiovascular diabetology2019 Jul 9PMID31288820doi:10.1186/s12933-019-0890-5via clinicaltrials gov reference derived + pubmed nct search

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.