Effect of liraglutide on physical performance in type 2 diabetes (LIPER2): A randomised, double-blind, controlled trial

• DOI: 10.1016/j.conctc.2016.06.007
• Publication Date: 2016-06-24T19:56:01Z
• Authors: Ana María Wägner; Guillermo Miranda...; Miren Arantza Uga...; Héctor Marrero-Sa...; Laura Suárez-Cast...; María del Pino Al...; Nuria Castillo-Ga...; María José López-...; Carolina Alemán; Carla Martínez-Ma...; Laura López-Ríos; Alicia Díez del Pino; Francisco Javier ...
• Keywords: Clinical endpoint

Preclinical studies and small clinical trials suggest that glucagon-like peptide 1 (GLP1) may have a positive effect on ventricular function. Liraglutide is GLP1-analogue used in the treatment of type 2 diabetes. LIPER2 phase IV, randomised, double-blind, placebo-controlled, parallel-design trial, assessing 6 months' liraglutide 1.8 mg/d measures cardiac function physical performance patients with A total 30 diabetes will be included, if their HbA1c between 7 10% while oral agents (including metformin tolerated not contraindicated), maximum intermediate or long-acting insulin injections per day combination both. After baseline examinations, are randomised to receive daily subcutaneous placebo injection (titrated tolerated) for months. The primary end-point maximal oxygen consumption during cycle ergometry at end study period. Other end-points include distance covered 6-min walk test, left ejection fraction other systolic diastolic functions assessed by echocardiography, heart rate, blood pressure, pro-brain natriuretic peptide, C-reactive protein, HbA1c, lipids, apolipoprotein B, body weight waist girth. Safety adverse event reporting, count, kidney liver function, amylase, lipase, electrolytes, calcitonin, CA19.9 pregnancy test fertile women. At time this report, recruitment still ongoing. Results expected reported December 2016.