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

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.