Type 2 diabetes mellitus and sublinical heart failure MedDRA version: 13.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 13.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Victoza
Product Code: EU/1/09/529/001-005
Pharmaceutical Form: Solution for injection
Trade Name: Glimepirid BMM Pharma
Product Name: Glimepirid BMM Pharma
Pharmaceu
Sponsors
Karolinska Institute, Södersjukhuset AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Type 2 diabetes. 2 Heart Failure, visualized with echocardiography, one of the following (2.1, 2.2 or 2.3). 2.1 Ejection Fraction = 50%. 2.2 Decreased systolic velocity (four chamber view) where two, out of four segments (Septum, Lateral, Inferior and Anterior Wall) has a relative decrease in velocity of 20% compared to a normal population. 2.3 Evidence of diastolic dysfunction as shown by abnormal left ventricular relaxation, filling, diastolic distensibility or stiffness. An E/E’ ratio (ratio of early diastolic velocities of mitral inflow derived Doppler imaging and myocardial movement derived by tissue Doppler imaging) >15 is considered diagnostic of diastolic dysfunction and an E/E' ratio 49 ml/ m2) and an increased left ventricular mass (>122 g/m2 in women and >149 g/m2 in men) are considered sufficient evidence of diastolic dysfunction when the E/E' ratio is inconclusive. 3 HbA1c (accordingly to IFCC) 60 mmol/mol – 95 mmol/mol. 4 If antihypertensive treatment, the medication has to be stable, no change, for the last 1 month. 5 Male and female subjects, 18-70 years of age. 6 Signed informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes (autoantibody positive). 2. Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors (DPP-IV inhibitor) or glimeperid. 3. Previous treatment with glitazones within 6 months. 4. Previous treatment with other sulphonylurea within 3 months. 5. Previous treatment with insulin (any regimen) within 1 month.. 6. Known severe heart failure, classified as NYHA 3-4. 7. Significant ischemic heart disease (defined as angina-limited exercise or unstable angina); documented acute myocardial infarction (MI) within the previous 8 weeks. 8. Active myocarditis; malfunctioning artificial heart valve. 9. Atria fibrillation or flutter 10. History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block. 11. Implanted pacemaker. 12. Supine systolic blood pressure 200 mm Hg? 13. Primary renal impairment (creatinine clearance 5.5 mmol/l). 15. Significant anemia (Hb 40 kg/m2. 19. Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Patients with intraepithelial squamous cell carcinoma of the skin treated with topical 5FU and subjects with basal cell skin cancer are allowed to enter the trial. 20. Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). 21. Current drug and alcohol abuse. 22. History of acute or chronic pancreatitis 23. Subjects considered by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether 18 weeks treatment of liraglutide (Victoza) will improve subclinical heart failure (measured with echocardiogram and tissue doppler) in type 2 diabetic subjects versus glimepiride both in combination with metformin ;Secondary Objective: To investigate the tolaribility of the 18 weeks use of Victoza in type 2 diabetic subjects with subclinical heart failure. ;Primary end point(s): Subjects achieving an absolute increase in left ventricle longitudinal function and/or functional reserve during rest and/or after exercise of 0.7 cm/s, i.e., ?E’ [1-(1/E’base)] or ?S’ [1-(1/S’base)] after 18 weeks of liraglutide + metformin, compared with glimepiride + metformin, using tissue Doppler echocardiography. | — |
Countries
Sweden
Outcome results
None listed