Overview of inclusion and exclusion criteria in the LIVE-study
| Inclusion criteria | |
|---|---|
| General | Patients with diabetes |
| ▸ Age 30–85 (both inclusive) ▸ CHF and LVEF≤45% (NYHA-class I, II or III) ▸ Stable and optimal pharmacological treatment of heart failure according to ESC guidelines and implantation of bi-ventricular pacemaker (if indicated) at minimum three months before randomisation ▸ Able to understand the written patient information and to give informed consent | ▸ T2D (WHO criteria), diagnosed at least 3 months before screening ▸ Stable dose of antidiabetic treatment for 30 days before randomisation ▸ Patients must be without antidiabetic treatment or treated with oral antidiabetic drugs and/or insulin, except fast-acting insulin |
| Exclusion criteria | |
| General | Cardiovascular |
| ▸ Known or suspected hypersensitivity to trial product or related products ▸ Alcohol/drug abuse ▸ Pregnant or nursing women ▸ Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives ▸ Cancer unless in complete remission for ≥5 years ▸ Liver disease with elevated plasma alanine aminotransferase of more than three times the upper limit of normal ▸ Inflammatory bowel disease ▸ Acute or chronic pancreatitis ▸ Compromised kidney function (eGFR <30 mL/min), dialysis or kidney transplantation ▸ History of thyroidea adenoma or carcinoma ▸ Severely elevated blood pressure (systolic >180 mm Hg and/or diastolic >105 mm Hg) ▸ Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation ▸ Participation in any other clinical intervention trial | ▸ CHF (NYHA class IV) ▸ Hospitalisation due to incompensated heart disease within 30 days prior to randomisation ▸ Myocardial infarction within the past 3 months before screening ▸ Coronary revascularisation within the past 3 months before screening ▸ Atrial fibrillation with ventricular frequency >100/min in rest ▸ ECG suggestive of malignant ventricular arrhythmia ▸ Prolonged QT-interval (>500 ms), unless caused by bundle branch block ▸ Uncorrected valvular heart disease ▸ Current myocardial or pericardial infection ▸ Obstructive hypertrophic cardiomyopathy ▸ Planned coronary revascularisation ▸ Poor image quality on echocardiography |
| Diabetes | |
| ▸ Type 1 diabetes ▸ HbA1c >10% measured at screening ▸ Use of GLP-1 receptor agonists (exenatide, liraglutide or other) or glitazones, pramlintide or any DPP-4 inhibitor within 30 days prior to randomisation ▸ Diabetic gastroparesis | |
CHF, chronic heart failure; DDP-4, dipeptidyl peptidase-4 inhibitor; eGFR, estimated-glomerular filtration rate; ESC, European Society of Cardiology; GLP-1, glucagon-like peptide 1; HbA1c, glycated haemoglobin; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; T2D, type 2 diabetes.