DelfaGLP-1 Atlas

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CompletedPhase 4

Effect of Liraglutide on Diastolic Dysfunction on Cardiac MRI in Type 2 Diabetes Patients

Influence of Liraglutide on Diastolic Cardiac Function and Myocardial Perfusion as Determined by Magnetic Resonance Imaging in Patients With Type 2 Diabetes: a Double-blind Randomized Parallel-group Trial

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

40

actual

Study population

Heart failure, Type 2 diabetes

Key I/E criterion

•EF ≥50%

Primary endpoint

•Diastolic properties

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 IDNCT02655770
Org study ID2015-000410-22

Timeline

Milestones

Study first posted2016-01-14estimated
Last update posted2021-01-14actual
Study start2016-02actual (month precision)
Primary completion2019-12actual (month precision)
Study completion2019-12actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Heart failureType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female patient fully capable of informed consent
•Informed consent
•Age 18-80 years (both years inclusive)
•T2DM diagnosed at least 3 months prior to visit 0
•NYHA class I-III at visit 0
•E/e* ≥ 9 or e* (lateral) ≤10 cm/sec, or both
•LVEF > 50%
•LVEDV/BSA < 97 ml/m2
•Stable on heart medication for 6 weeks prior to randomisation
•Stable on antidiabetic treatment for 30 days prior to randomisation
•T2DM must be either treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs

Exclusion criteria

•Lack of consent.
•NYHA class IV
•Type 1 diabetes mellitus
•Incretin-based therapy (GLP-1 receptor agonists; exenatide, liraglutide or other and DPP-IV inhibitors) within 30 days prior to randomisation (visit 1)
•Glitazon therapy within 30 days prior to randomisation (visit 1)
•Hypertension with inadequate blood pressure control: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure >85 mmHg*
•Supine systolic blood pressure <85 mmHg measured at visit 0
•Significant valvular heart disease
•Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis
•Myocardial infarction, unstable angina, angina on exertion (≥CCS class 2) or coronary revascularization within 3 months prior to randomisation (visit 1)
•Hospitalisation due to incompensated heart disease within 30 days to randomisation (visit 1)
•HbA1c >10% at visit 0
•eGFR< 60 ml/min/1,73 m2 at visit 0
•Liver disease with aspartate aminotransferase/alanine aminotransferase >3 times upper limit of normal measured at visit 0**
•Hypokalaemia (P-potassium <3.5 mmol/L) or hyperkalaemia (P-potassium >5.5 mmol/L) measured at visit 0**
•Anaemia (haemoglobin <6.5 mmol/L) measured at visit 0**
•Conditions that may be associated with changes in markers of fibroses or collagen turnover (eg. on-going or active rheumatological disease requiring anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
•Prolonged use (> 2 weeks) of glucocorticoids or NSAIDs within 2 weeks prior to visit 0
•Women of childbearing potential who are not on acceptable contraception. See below.
•Pregnant or breastfeeding women
•Cancer (except basal cell skin cancer or squamous cell skin cancer) unless complete remission for ≥ 5 years
•Alcohol/drug abuse
•Chronic or previous acute pancreatitis
•History of thyroid adenoma or carcinoma
•Inflammatory bowel disease
•Clinical signs of diabetic gastroparesis
•ICD/pacemaker or other contraindications to MRI scan
•Severe claustrophobia
•Atrial fibrillation
•Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
•Known or suspected hypersensitivity to trial product or related products
•Current participation in any other clinical intervention trial
•Receipt of an investigational drug with 30 days prior to visit 0
•Other concominant disease or treatment that according to investigator's assessment makes the patient unsuitable for participation in the study
–Measured twice at visit 0. In case of elevation, an ambulatory (24-hour) blood pressure will be performed, and the result of this will be conclusive
–Measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value will be conclusive.

Endpoints (4)

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.

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Change in diastolic properties as assessed by CMR.

Time frame:Measured in week 18 and compared to baseline.

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Change in diastolic properties as assessed by CMR.

Time frame:Measured in week 18 and compared to baseline.

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

MRI indices of myocardial perfusion

Time frame:Measured in week 18 and compared to baseline.

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Echocardiographic indices of diastolic dysfunction

Time frame:Measured in week 18 and compared to baseline.

change from baseline, descriptive

Publications (10)

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

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.