Effects on subclinical heartfailure in type 2 diabetic subjects on liraglutide treatment versus glimepiride both in combination with metformin.

INTERVENTION: 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 Pharmaceutical Form: Tablet Trade Name: Metformin Actavis Product Name: Metformin Actavis Pharmaceutical Form: Film‐coated tablet CONDITION: 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 PRIMARY OUTCOME: 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 ; ; ; ; 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. Secondary Objective: To investigate the tolaribility of the 18 weeks use of Victoza in type 2 diabetic subjects with subclinical heart failure. 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 < 8 as diagnostic of the absence of diastolic heart failure. An increased left atrial size (>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' r