| Trial ID: | L3875 |
| Source ID: | NCT02889510
|
| Associated Drug: |
Liraglutide
|
| Title: |
Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02889510/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: liraglutide|DRUG: placebo
|
| Outcome Measures: |
Primary: Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1), Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second (FEV1). Mean difference between 7 weeks after treatment visit and baseline visit is registered., 7 weeks | Secondary: Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC), Changes from baseline on measurements of respiratory function defined by forced vital capacity (FVC). Mean difference between 7 weeks after treatment visit and baseline visit is registered., 7 weeks|Changes From Baseline in Serum Levels of Surfactant A and D Protein, Changes from baseline in serum levels of surfactant A and D protein. Values for surfactant A or D protein after 7 treatment weeks (liraglutide or placebo) are registered., 7 weeks|Changes From Baseline on Measurements of Respiratory Function Defined by Maximum Mid-expiratory Flow (FEF25-75), Changes from baseline on measurements of respiratory function defined by Maximum mid-expiratory flow (FEF25-75). Mean difference between 7 weeks after treatment visit and baseline visit is registered., 7 weeks|Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC), Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC). Mean difference between 7 weeks after treatment visit and baseline visit is registered., 7 weeks|Changes From Baseline on Measurements of Respiratory Function Defined by Residual Volume (RV), Changes from baseline on measurements of respiratory function defined by residual volume (RV)., 7 weeks|Changes From Baseline on Measurements of Respiratory Function Defined by Total Lung Capacity (TLC), Changes from baseline on measurements of respiratory function defined by Total lung capacity (TLC)., 7 weeks|Changes From Baseline on Measurements of Respiratory Function Defined by Residual Functional Capacity (RFC), Changes from baseline on measurements of respiratory function defined by Residual functional capacity (RFC) are registered. However, this parameter was not determined in patients due to an error in the programm used., 7 weeks
|
| Sponsor/Collaborators: |
Sponsor: Lecube, Albert, M.D. | Collaborators: Dynamic Solutions|Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
76
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-10-04
|
| Completion Date: |
2019-12-16
|
| Results First Posted: |
2021-02-26
|
| Last Update Posted: |
2021-02-26
|
| Locations: |
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, 08916, Spain|Clínica Universidad de Navarra, Pamplona, Navarra, 31008, Spain|Hospital Universitari Vall d´Hebrón, Barcelona, 08035, Spain|Hospital Universitari Arnau de Vilanova de Lleida, Lleida, 25198, Spain|Hospital Universitario Virgen de la Victoria, Málaga, 29010, Spain|Hospital Universitario Virgen del Rocío, Sevilla, 41013, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT02889510
|
