RESUMO
AIMS: To assess the effect of the GLP-1 analogue liraglutide on measures of cardiac function and physical performance in patients with type 2 diabetes (T2D). METHODS: In this phase-IV randomized double-blind placebo-controlled parallel-group clinical trial at a tertiary hospital, T2D patients with HbA1c levels of 7-10% with oral agents and/or intermediate-/long-acting insulin were allocated (computer-generated randomization, ratio 1:1) to either liraglutide 1.8 mg/day or a placebo for 6 months. The primary endpoint was maximum oxygen consumption (VO2max) during cycle ergometry, while other procedures included a 6-min walk test, echocardiography, anthropometry and blood tests. Safety endpoints were also monitored, and an intention-to-treat analysis was performed. RESULTS: A total of 24 patients (15 women) aged 52 (11.7) years, with diabetes duration of 8.7 (5.8) years, BMI 34.98 (6.2) kg/m2 and HbA1c 8.2% (0.68%), were randomized to liraglutide 1.8 mg daily or placebo. There were no differences in VO2max [17.98 (4.8) vs. 15.90 (4.96) mL/kg/min; P > 0.10], VE/VCO2 slope [30.18 (4.8) vs. 32 (4.49)], left ventricular ejection fraction or 6-min walk test [530.7 (86) vs. 503.9 (84) m] at 6 months. HbA1c was lower (6.7% vs. 7.7%; P = 0.005), with a trend towards lower maximum systolic blood pressure during ergometry [171.7 (24.4) vs. 192.5 (25.6); P = 0.052] in the liraglutide group at the end of the study. There were no severe adverse events. CONCLUSION: In this trial, liraglutide improved glycaemic control in T2D, but had no significant effects on either physical performance or myocardial function.
