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

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac MRI. Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Novo Nordisk A/S; Slagelse Hospital
• Treatments: Liraglutide

Criteria

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.