Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo
Intervention description: 7-week subcutaneous liraglutide once daily; 7-week subcutaneous placebo once daily
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: diabetes; liraglutide; lung function

Summary:

      Type 2 diabetes (T2DM) is related to reduced pulmonary function. As experimental studies with
      glucagon-like peptide 1 (GLP-1) have shown an increase in pulmonary surfactant secretion, and
      the GLP-1 receptor has been found in significant amounts in the lung, it could be
      hypothesized that the treatment with liraglutide (a GL-1 agonist) will improve this reduced
      pulmonary function
    

Eligibility criteria:

        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
             thiazolidinediones) 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

        Exclusion Criteria:

          -  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 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 (Alanine transaminase/ Aspartate
             Aminotransferase 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).