Type 2 diabetes mellitus and diastolic heart faliure MedDRA version: 18.0 Level: LLT Classification code 10069211 Term: Diastolic heart failure System Organ Class: 100000004849 MedDRA version: 18.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
The Cardiovascular MR Group, Dept. 2011, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion 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 • NYHA class I-III • E/e* = 9 or e* (lateral) =10 cm/sec, or both • LVEF > 50% • LVEDV/BSA =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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 randomization • Glitazon therapy within 30 days prior to randomization • Hypertension with inadequate blood pressure control: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure >85 mmHg • Supine systolic blood pressure 10% • eGFR3 times upper limit of normal • Hypokalaemia (P-potassium 5.5 mmol/L) • Anaemia (haemoglobin 2 weeks) of glucocorticoids or NSAIDs within 2 weeks prior to the beginning of the trail • Women of childbearing potential who are not on acceptable contraception • 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 at rest, 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 the beginning of the trail • Other concominant disease or treatment that according to investigator’s assessment makes the patient unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to test if 18 weeks of treatment with liraglutide (up to 1.8 mg s.c. once daily) improves (or worsens) diastolic performance in T2DM patients with diastolic dysfunction, compared to placebo.;Secondary Objective: The secondary objectives of this trial are to evaluate whether 18 weeks of treatment with liraglutide (up to 1.8 mg s.c. once daily) improves (or worsen) myocardial perfusion and echocardiographic indices of diastolic dysfunction in T2DM patients with diastolic dysfunction, compared to placebo.;Primary end point(s): The primary endpoints will be change in diastolic properties as assessed by cardiac MRI: •LA passive emptying fraction (%) •LV peak filling rate (LVPFR) (ml/s) ;Timepoint(s) of evaluation of this end point: Measured during week 18 (on medication, placebo/liraglutide) and compared to baseline (before placebo/liraglutide treatment is started) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints consist of changes in: • MRI indices of myocardial perfusion • echocardiographic indices of diastolic dysfunction;Timepoint(s) of evaluation of this end point: Measured during week 18 (on medication, placebo/liraglutide) and compared to baseline (before placebo/liraglutide treatment is started) | — |
Countries
Denmark
Contacts
Public ContactAtt: Annemie Bojer/Niels Vejlstrup
The Cardiovascular MR Group, Dept. 2011, Rigshospitalet
Outcome results
None listed