Clinical trial: Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus (NCT02889510)

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).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment