GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

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

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)

Lead sponsor

Lecube, Albert, M.D.

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 30-40•HbA1c ≥7%

Primary endpoint

•Changes From Baseline on Measurements of Respiratory Function

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02889510

Org study IDLIRALUNG

Timeline

Milestones

Study first posted2016-09-05estimated

Study start2016-10-04actual

Primary completion2019-11-18actual

Study completion2019-12-16actual

Last update posted2021-02-26actual

Results first posted2021-02-26actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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).

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Other (unclassified)

Other clinical outcomes

15 endpoints

Primary/registry result

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1)

Time frame:7 weeks

change from baseline, improvement

Posted result

Group	Value (mean), % (FEV1)	95% CI
Liraglutide	4.1	0.0 – 8.3
Placebo	4.3	0.1 – 8.5

Primary/protocol endpoint

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1)

Time frame:7 weeks

change from baseline, improvement

Secondary/registry result

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC)

Time frame:7 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), % (FVC)	95% CI
Liraglutide	5.4	2.1 – 8.7
Placebo	0.2	-2.5 – 3.1

Secondary/registry result

Changes From Baseline in Serum Levels of Surfactant A and D Protein

Time frame:7 weeks

change from baseline, improvement

Posted result

Group	Value (median), ng/ml	95% CI
LiraglutideA protein	40.9	30.8 – 44.5
D protein	169.6	108.1 – 233.6
PlaceboA protein	41.3	21.5 – 50.3
D protein	201.5	115.3 – 284.7

Secondary/registry result

Changes From Baseline on Measurements of Respiratory Function Defined by Maximum Mid-expiratory Flow (FEF25-75)

Time frame:7 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), % (FEF25-75)	95% CI
Liraglutide	8.0	-4.1 – 20.1
Placebo	12.5	2.2 – 22.8

Secondary/registry result

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC)

Time frame:7 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), % (FEV1/FVC)	95% CI
Liraglutide	-2.1	-5.1 – 0.9
Placebo	1.7	-0.8 – 4.2

Secondary/registry result

Changes From Baseline on Measurements of Respiratory Function Defined by Residual Volume (RV)

Time frame:7 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), % (RV)	95% CI
Liraglutide	3.2	-17.5 – 24.1
Placebo	-1.1	-25.4 – 23.1

Secondary/registry result

Changes From Baseline on Measurements of Respiratory Function Defined by Total Lung Capacity (TLC)

Time frame:7 weeks

change from baseline, improvement

Posted result

Group	Value (mean), % (TLCO)	95% CI
Liraglutide	-2.6	-11.9 – 6.6
Placebo	-3.1	-9.5 – 3.2

Secondary/registry result/low confidence

Changes From Baseline on Measurements of Respiratory Function Defined by Residual Functional Capacity (RFC)

Time frame:7 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC)

Time frame:7 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes From Baseline on Measurements of Respiratory Function Defined by Maximum Mid-expiratory Flow (FEF25-75)

Time frame:7 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC)

Time frame:7 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes From Baseline on Measurements of Respiratory Function Defined by Residual Volume (RV)

Time frame:7 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes From Baseline on Measurements of Respiratory Function Defined by Total Lung Capacity (TLC)

Time frame:7 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes From Baseline on Measurements of Respiratory Function Defined by Residual Functional Capacity (RFC)

Time frame:7 weeks

change from baseline, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Changes From Baseline in Serum Levels of Surfactant A and D Protein

Time frame:7 weeks

change from baseline, descriptive

Publications (11)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Liraglutide Improves Forced Vital Capacity in Individuals With Type 2 Diabetes: Data From the Randomized Crossover LIRALUNG Study.
Diabetes2022 Feb 1PMID34737187doi:10.2337/db21-0688via clinicaltrials gov reference derived + pubmed nct search
Insulin resistance is related to impaired lung function in morbidly obese women: a case-control study.
Diabetes/metabolism research and reviews2010 Nov (month)PMID20882512doi:10.1002/dmrr.1131via CT.gov background
Type 2 diabetes impairs pulmonary function in morbidly obese women: a case-control study.
Diabetologia2010 Jun (month)PMID20217039doi:10.1007/s00125-010-1700-5via CT.gov background
Diabetes is an independent risk factor for severe nocturnal hypoxemia in obese patients. A case-control study.
PloS one2009 (year)PMID19262746doi:10.1371/journal.pone.0004692via CT.gov background
Prevalence and outcomes of diabetes, hypertension and cardiovascular disease in COPD.
The European respiratory journal2008 Oct (month)PMID18579551doi:10.1183/09031936.00012408via CT.gov background
Circulating surfactant protein A (SP-A), a marker of lung injury, is associated with insulin resistance.
Diabetes care2008 May (month)PMID18285549doi:10.2337/dc07-2173via CT.gov background
Cross-sectional and prospective study of lung function in adults with type 2 diabetes: the Atherosclerosis Risk in Communities (ARIC) study.
Diabetes care2008 Apr (month)PMID18056886doi:10.2337/dc07-1464via CT.gov background
Glycemic exposure is associated with reduced pulmonary function in type 2 diabetes: the Fremantle Diabetes Study.
Diabetes care2004 Mar (month)PMID14988297doi:10.2337/diacare.27.3.752via CT.gov background
Pulmonary involvement in diabetes mellitus.
Romanian journal of internal medicine = Revue roumaine de medecine interne2003 (year)PMID15526520via CT.gov background
Glucagon-like peptide-1(7-36) amide stimulates surfactant secretion in human type II pneumocytes.
American journal of respiratory and critical care medicine2001 Mar (month)PMID11282754doi:10.1164/ajrccm.163.4.9912132via CT.gov background
Reduced pulmonary function and its associations in type 2 diabetes: the Fremantle Diabetes Study.
Diabetes research and clinical practice2000 Oct (month)PMID10960726doi:10.1016/s0168-8227(00)00166-2via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.