Phase 3 · Liraglutide

NCT02889510 trial results

Multicentre Randomized Double Blind, Crossover, Placebo Controlled Clinical Trial to Evaluate the Effect of Liraglutide on Lung Function in Patients With Type 2 Diabetes Mellitus (LIRALUNG Study)

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1) (% (FEV1)), 7 weeks. Liraglutide: 4.1; Placebo: 4.3.

Participants
76
Status
completed
Completed
2019-12-16
Sponsor
Lecube, Albert, M.D.

As posted on ClinicalTrials.gov (NCT02889510), updated at source Feb 26, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02889510 measured first

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1)% (FEV1) · 7 weeks · mean
Liraglutiden=50Placebon=50
4.1(0.0 to 8.3)4.3(0.1 to 8.5)
Side effects by arm

Side effects in NCT02889510

Percent of participants affected, 7 weeks of treatment.. The most common events the registry lists.

EventLiraglutidePlacebo
Any serious event0%1.4%
Gastrointestinal disorders27.1%5.7%
Infections and infestations1.4%4.3%
Metabolism and nutrition disorders0%4.3%
Nervous system disorders2.9%2.9%
Skin and subcutaneous tissue disorders1.4%2.9%
Respiratory, thoracic and mediastinal disorders1.4%2.9%
Renal and urinary disorders2.9%1.4%
General disorders and administration site conditions2.9%0%
Cardiac disorders1.4%1.4%
Traumatic injuries, poisonings and complications of therapeutic procedures0%1.4%
Congenital, family and genetic disorders0%1.4%
Musculoskeletal and connective tissue disorders0%1.4%
Secondary outcomes

What else it measured

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC)% (FVC) · 7 weeks · mean
Liraglutiden=50Placebon=50
5.4(2.1 to 8.7)0.2(-2.5 to 3.1)
Changes From Baseline in Serum Levels of Surfactant A and D Proteinng/ml · 7 weeks · median
MeasureLiraglutiden=48Placebon=48
A protein40.9(30.8 to 44.5)41.3(21.5 to 50.3)
D protein169.6(108.1 to 233.6)201.5(115.3 to 284.7)
Changes From Baseline on Measurements of Respiratory Function Defined by Maximum Mid-expiratory Flow (FEF25-75)% (FEF25-75) · 7 weeks · mean
Liraglutiden=46Placebon=46
8.0(-4.1 to 20.1)12.5(2.2 to 22.8)
Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC)% (FEV1/FVC) · 7 weeks · mean
Liraglutiden=50Placebon=50
-2.1(-5.1 to 0.9)1.7(-0.8 to 4.2)
Changes From Baseline on Measurements of Respiratory Function Defined by Residual Volume (RV)% (RV) · 7 weeks · mean
Liraglutiden=12Placebon=12
3.2(-17.5 to 24.1)-1.1(-25.4 to 23.1)
Changes From Baseline on Measurements of Respiratory Function Defined by Total Lung Capacity (TLC)% (TLCO) · 7 weeks · mean
Liraglutiden=12Placebon=12
-2.6(-11.9 to 6.6)-3.1(-9.5 to 3.2)
The trial

How NCT02889510 was run

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

  • liraglutide: 7-week subcutaneous liraglutide treatment once daily
  • placebo: 7-week subcutaneous placebo treatment once daily.
Who could join the trial

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).

Published papers

Papers from NCT02889510

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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