Overview

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.