Last updated on September 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM | Myocardial Perfusion | Cardiac MRI | Diastolic Dysfunction
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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