Wägner Ana María, Miranda-Calderín Guillermo, Ugarte-Lopetegui Miren Arantza, Marrero-Santiago Héctor, Suárez-Castellano Laura, Alberiche-Ruano María Del Pino, Castillo-García Nuria, López-Madrazo María José, Alemán Carolina, Martínez-Mancebo Carla, López-Ríos Laura, Díez Del Pino Alicia, Nóvoa-Mogollón Francisco Javier
Endocrinology and Nutrition Department, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Av Marítima s/n, 35016, Las Palmas de Gran Canaria, Spain.
Instituto Universitario de Investigaciones Biomédicas y Sanitarias (IUIBS), Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.
Contemp Clin Trials Commun. 2016 Jun 24;4:46-51. doi: 10.1016/j.conctc.2016.06.007. eCollection 2016 Dec 15.
Preclinical studies and small clinical trials suggest that glucagon-like peptide 1 (GLP1) may have a positive effect on ventricular function. Liraglutide is a GLP1-analogue used in the treatment of type 2 diabetes. LIPER2 is a phase IV, randomised, double-blind, placebo-controlled, parallel-design trial, assessing the effect of 6 months' liraglutide 1.8 mg/d on measures of cardiac function and physical performance in patients with type 2 diabetes. A total of 30 patients with type 2 diabetes will be included, if their HbA1c is between 7 and 10% while on oral agents (including metformin if tolerated and not contraindicated), a maximum of 2 intermediate or long-acting insulin injections per day or a combination of both. After their baseline examinations, patients are randomised to receive a daily subcutaneous liraglutide or placebo injection (titrated to 1.8 mg/d if tolerated) for 6 months. The primary end-point is the maximal oxygen consumption during cycle ergometry at the end of the study period. Other end-points include distance covered during a 6-min walk test, left ventricular ejection fraction and other measures of ventricular systolic and diastolic functions assessed by echocardiography, heart rate, blood pressure, pro-brain natriuretic peptide, C-reactive protein, HbA1c, lipids, apolipoprotein B, body weight and waist girth. Safety end-points include adverse event reporting, blood count, kidney and liver function, amylase, lipase, electrolytes, calcitonin, CA19.9 and pregnancy test for fertile women. At the time of this report, recruitment is still ongoing. Results are expected to be reported in December 2016.
临床前研究和小型临床试验表明，胰高血糖素样肽1（GLP1）可能对心室功能产生积极影响。利拉鲁肽是一种用于治疗2型糖尿病的GLP1类似物。LIPER2是一项IV期、随机、双盲、安慰剂对照、平行设计试验，评估2型糖尿病患者每日皮下注射1.8mg利拉鲁肽，持续6个月对心脏功能和身体机能指标的影响。如果2型糖尿病患者糖化血红蛋白（HbA1c）在7%至10%之间，正在服用口服药物（若耐受且无禁忌，包括二甲双胍），每天最多注射2次中效或长效胰岛素或两者联用，则总共将纳入30例此类患者。在进行基线检查后，患者被随机分组，接受每日皮下注射利拉鲁肽或安慰剂（若耐受则滴定至1.8mg/d），持续6个月。主要终点是研究期末次运动平板试验期间的最大耗氧量。其他终点包括6分钟步行试验中的行走距离、左心室射血分数以及通过超声心动图评估的心室收缩和舒张功能的其他指标、心率、血压、脑钠肽前体、C反应蛋白、HbA1c、血脂、载脂蛋白B、体重和腰围。安全性终点包括不良事件报告、血细胞计数、肾功能和肝功能、淀粉酶、脂肪酶、电解质、降钙素、CA19.9以及对有生育能力女性的妊娠试验。在本报告发布时，招募工作仍在进行中。预计结果将于2016年12月公布。
