MULTICENTRE RANDOMIZED DOUBLE BLIND, CROSSOVER, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF LIRAGLUTIDE ON LUNG FUNCTION IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (LIRALUNG STUDY) - LIRALUNG

Dr. Albert Lecube, Ph.D., M.D.0 个研究点目标入组 76 人开始时间: 2016年2月23日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•Signed informed consent.
•Subjects between 40 and 65 years old.
•Diagnosis of type 2 diabetes mellitus with more than 5 years of evolution of disease.
•Metformin ( alone or in combination with sulfonylurea and / or insulin and / or tiazolidinendionas ) at a stable dose for at least the past 3 months.
•HbA1c ? 7,0 y ? 9,0 %.
•BMI between 30 and 40 kg / m2.
•No pulmonary disease (COPD, asthma, fibrosis, etc) known.
•Baseline FEV1 decline of equal or greater than 10% in the percentage of the theoretical value.
•Chest radiography without significant changes in the lung parenchyma .
•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 76
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Type 1 diabetes mellitus
•Treatment with inhibitors of dipeptidyl peptidase 4 glitazones and / or SGLT2 inhibitors.
•Active and former smokers for less than five years ago smoking.
•Chronic obstructive pulmonary disease.
•Respiratory sleep disorders that require treatment with CPAP (continuous positive pressure in the airway).
•Asthma treatment with bronchodilators.
•Previous bariatric surgery.
•Cardiovascular disease, heart failure and / or stroke.
•Pathology of the chest wall.
•Serum creatinine> 1.7 mg / dl.
•Abnormal results in liver function test (ALT / AST greater than twice the upper limit of normal).
•History of acute or chronic pancreatitis.
•Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia (MEN ) type 2.
•Active neoplasms or neoplastic patients considered disease-free history from less than 5 years ago.
•Women of childbearing age who are pregnant (positive pregnancy test within 14 days before the start of treatment) or intend to get pregnant.
•Lactating women.
•Women of childbearing potential not using adequate contraception (such as oral contraceptives, intrauterine device or barrier method of birth control along with spermicide or surgical sterilization) or unwilling to use during the study (as required by local laws or practices).

发起方

Dr. Albert Lecube, Ph.D., M.D.