Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2019-12-16
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lecube, Albert, M.D.
• Collaborators: Dynamic Solutions; Novo Nordisk A/S
• Treatments: Liraglutide

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).