DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01425580

CompletedPhase 2

Liraglutide and Heart Failure in Type 2 Diabetes

Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment Versus Glimepiride Both in Combination With Metformin

Lead sponsor

Thomas Nystrom

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

62

actual

Study population

Heart failure, Type 2 diabetes

Key I/E criterion

•EF ≤50%

Primary endpoint

•Left ventricle longitudinal function and/or functional reserve during rest

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 IDNCT01425580
Org study IDEU-nr 2010-022695-31
Secondary ID2010-022695-31

Timeline

Milestones

Study first posted2011-08-30estimated
Last update posted2016-09-01estimated
Study start2012-01 (month precision)
Primary completion2016-08actual (month precision)
Study completion2016-08actual (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

1. Type 2 diabetes.

2. Heart Failure, visualized with echocardiography, one of the following (2.1, 2.2 or 2.3).

–Ejection Fraction ≤ 50%.
–Decreased systolic velocity (four chamber view) where two, out of four segments (Septum, Lateral, Inferior and Anterior Wall) has a relative decrease in velocity of 20% compared to a normal population.
–Evidence of diastolic dysfunction as shown by abnormal left ventricular relaxation, filling, diastolic distensibility or stiffness. An E/E' ratio (ratio of early diastolic velocities of mitral inflow derived Doppler imaging and myocardial movement derived by tissue Doppler imaging) >15 is considered diagnostic of diastolic dysfunction and an E/E' ratio < 8 as diagnostic of the absence of diastolic heart failure. An increased left atrial size (>49 ml/ m2) and an increased left ventricular mass (>122 g/m2 in women and >149 g/m2 in men) are considered sufficient evidence of diastolic dysfunction when the E/E' ratio is inconclusive.

3. HbA1c (accordingly to IFCC) 47 mmol/mol - 95 mmol/mol.

4. If antihypertensive treatment, the medication has to be stable, no change, for the last 1 month.

5. Male and female subjects, 18-80 years of age.

6. Signed informed consent form.

Exclusion criteria

1. Type 1 diabetes (autoantibody positive).

2. Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors (DPP-IV inhibitor) or glimeperide.

3. Previous treatment with glitazones within 6 months.

4. Previous treatment with other sulphonylurea within 3 months.

5. Previous treatment with insulin (any regimen) within 1 month.

6. Known severe heart failure, classified as NYHA 3-4.

7. Significant ischemic heart disease (defined as angina-limited exercise or unstable angina); documented acute myocardial infarction (MI) within the previous 8 weeks.

8. Active myocarditis; malfunctioning artificial heart valve.

9. Atria fibrillation or flutter

10. History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block.

11. Implanted pacemaker.

12. Supine systolic blood pressure <85 mm Hg or >200 mm Hg.

13. Primary renal impairment (creatinine clearance < 30 ml/min), or creatinine clearance < 60 ml/min if treated with metformin.

14. Uncorrected hypokalemia or hyperkalemia (potassium <3.5 mmol/l or >5.5 mmol/l).

15. Significant anemia (Hb < 90 g/l)

16. Treatment with another investigational agent within 30 days before study entry, judged by the investigator.

17. Severe gastrointestinal disease, including gastroparesis. As judged by the investigator.

18. Body mass index (BMI) > 40 kg/m2.

19. Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Patients with intraepithelial squamous cell carcinoma of the skin treated with topical 5FU and subjects with basal cell skin cancer are allowed to enter the trial.

20. Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice).

21. Current drug and alcohol abuse.

22. History of acute or chronic pancreatitis

23. Subjects considered by the investigator to be unsuitable for the study.

Endpoints (14)

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

Cardiometabolic biomarkers
4
Heart failure
3
Other (unclassified)
2
Weight & body composition
1
Glycemic / diabetes
1
Patient-reported / QoL
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body weight

Time frame:18 weeks

descriptive, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

A1c

Time frame:18 week

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

3 endpoints
Primary/protocol endpoint/low confidence

Left ventricle longitudinal function and/or functional reserve during rest and/or after exercise using tissue Doppler echocardiography

Time frame:18 weeks

descriptive

Secondary/protocol endpoint/low confidence

N-terminal pro b-type natriuretic peptide (NT-proBNP) levels in serum over time and symptoms of dyspnea or fatigue as assessed by patient and clinician using established scoring systems

Time frame:18 weeks

change from baseline, improvement

componentsNT-proBNP, change, PGI, change

Secondary/protocol endpoint

Global LV function (echocardiography) expressed as ejection fraction (EF)

Time frame:18 weeks

descriptive

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

24-hour blood pressure

Time frame:18 weeks

descriptive, improvement

Secondary/protocol endpoint

Plasma markers of inflammation i.e. hsCRP, IL-6, TNF-α and PAI-1

Time frame:18 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Plasma markers of endothelial activation i.e. E-selectin, VCAM-1, ICAM-1 and plasma levels of nitrate/nitrite

Time frame:18 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Lipids

Time frame:18 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Quality of life (SF 36)

Time frame:18 weeks

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events in terms of hypoglycaemia

Time frame:18 weeks

descriptive, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Exercise ECG, including working capacity

Time frame:18 weeks

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Energy delivering from the carotid artery

Time frame:18 weeks

descriptive

Secondary/protocol endpoint/low confidence

Gene and protein expression (Affymetrix/proteomics)

Time frame:18 weeks

descriptive

Publications (3)

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.