Type 2 Diabetes
Conditions
Interventions
Trade Name: Victoza
Product Name: Liraglutida
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
Sponsors
Dr. Albert Lecube, Ph.D., M.D.
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 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 ;Primary end point(s): Forced expiratory volume in one second (FEV1); Timepoint(s) of evaluation of this end point: Basal / screening visit Visit during the treatment period in weeks 11 and 18 l | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ; 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. | — |
Countries
Spain
Contacts
Public ContactDepartamento de Operaciones
Dynamic Science S.L.
Outcome results
None listed