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)

INTERVENTION: Trade Name: Victoza Product Name: Liraglutida Pharmaceutical Form: Solution for injection in pre‐filled pen INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656‐20‐2 Other descriptive name: Victoza Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] Type 2 Diabetes PRIMARY OUTCOME: Main Objective: To evaluate the effect of treatment with liraglutide versus placebo on forced expiratory volume in one second (FEV1) in patients with type 2 diabetes mellitus Primary end point(s): Forced expiratory volume in one second (FEV1) Secondary Objective: ‐ To evaluate the effect of treatment with liraglutide versus placebo on various other related respiratory function parameters; ‐ To evaluate the effect of treatment with liraglutide versus placebo on respiratory parameters during sleep; ‐ To evaluate the effect of treatment with liraglutide versus placebo on serum proteins A and D of pulmonary surfactant Timepoint(s) of evaluation of this end point: Basal / screening visit; Visit during the treatment period in weeks 11 and 18; l SECONDARY OUTCOME: Secondary end point(s): Other parameters derived from spirometry:; ‐ Forced vital capacity (FVC,); ‐ Maximum average expiratory flow (FEF 25‐75); ‐ FEV1 / FVC; ; Parameters derived from measurements of static lung volumes:; ‐ Residual volume (RV); ‐ Total lung capacity (TLC); ‐ Residual functional capacity (RFC, its acronym in English); ; Transfer factor of the lung for carbon monoxide (DLCO); ; 6‐minute walk test; ; Parameters of an unassisted home respiratory polygraphy:; ‐ Apnea‐hypopnea index; ‐ Percentage of accumulated time with oxygen saturation less than 90% (TA90).; ; Serum surfactant protein A and D in serum. Timepoint(s) of evaluation of this end point: Basal / screening visit; Visit during the treatment period in weeks 2, 7, 13 and 18; Visit end of treatment or early withdrawal INCLUSION CRITERIA: 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