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

NCT02889510 | Completed Phase 3 Results

• 1 other identifier: LIRALUNG
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Type 2 Diabetes

Keywords

diabetes; liraglutide; lung function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  7 weeks

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

  7 weeks

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

  7 weeks

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

  7 weeks

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

  7 weeks

Study Arms (2)

liraglutide

OTHER

7-week subcutaneous liraglutide treatment once daily

Drug: liraglutide

placebo

OTHER

7-week subcutaneous placebo treatment once daily.

Drug: placebo

Interventions

liraglutide DRUG

7-week subcutaneous liraglutide once daily

liraglutide

placebo DRUG

7-week subcutaneous placebo once daily

placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lecube, Albert, M.D.: lead
• Dynamic Solutions: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (6)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitari Vall d´Hebrón

Barcelona, 08035, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Related Publications (11)

• Davis TM, Knuiman M, Kendall P, Vu H, Davis WA. Reduced pulmonary function and its associations in type 2 diabetes: the Fremantle Diabetes Study. Diabetes Res Clin Pract. 2000 Oct;50(2):153-9. doi: 10.1016/s0168-8227(00)00166-2.

  PMID: 10960726 BACKGROUND

• Yeh HC, Punjabi NM, Wang NY, Pankow JS, Duncan BB, Cox CE, Selvin E, Brancati FL. Cross-sectional and prospective study of lung function in adults with type 2 diabetes: the Atherosclerosis Risk in Communities (ARIC) study. Diabetes Care. 2008 Apr;31(4):741-6. doi: 10.2337/dc07-1464. Epub 2007 Dec 4.

  PMID: 18056886 BACKGROUND

• Vara E, Arias-Diaz J, Garcia C, Balibrea JL, Blazquez E. Glucagon-like peptide-1(7-36) amide stimulates surfactant secretion in human type II pneumocytes. Am J Respir Crit Care Med. 2001 Mar;163(4):840-6. doi: 10.1164/ajrccm.163.4.9912132.

  PMID: 11282754 BACKGROUND

• Lecube A, Sampol G, Munoz X, Lloberes P, Hernandez C, Simo R. Insulin resistance is related to impaired lung function in morbidly obese women: a case-control study. Diabetes Metab Res Rev. 2010 Nov;26(8):639-45. doi: 10.1002/dmrr.1131. Epub 2010 Sep 29.

  PMID: 20882512 BACKGROUND

• Lecube A, Sampol G, Munoz X, Hernandez C, Mesa J, Simo R. Type 2 diabetes impairs pulmonary function in morbidly obese women: a case-control study. Diabetologia. 2010 Jun;53(6):1210-6. doi: 10.1007/s00125-010-1700-5. Epub 2010 Mar 9.

  PMID: 20217039 BACKGROUND

• Lecube A, Sampol G, Lloberes P, Romero O, Mesa J, Hernandez C, Simo R. Diabetes is an independent risk factor for severe nocturnal hypoxemia in obese patients. A case-control study. PLoS One. 2009;4(3):e4692. doi: 10.1371/journal.pone.0004692. Epub 2009 Mar 5.

  PMID: 19262746 BACKGROUND

• Fernandez-Real JM, Chico B, Shiratori M, Nara Y, Takahashi H, Ricart W. Circulating surfactant protein A (SP-A), a marker of lung injury, is associated with insulin resistance. Diabetes Care. 2008 May;31(5):958-63. doi: 10.2337/dc07-2173. Epub 2008 Feb 19.

  PMID: 18285549 BACKGROUND

• Mannino DM, Thorn D, Swensen A, Holguin F. Prevalence and outcomes of diabetes, hypertension and cardiovascular disease in COPD. Eur Respir J. 2008 Oct;32(4):962-9. doi: 10.1183/09031936.00012408. Epub 2008 Jun 25.

  PMID: 18579551 BACKGROUND

• Davis WA, Knuiman M, Kendall P, Grange V, Davis TM; Fremantle Diabetes Study. Glycemic exposure is associated with reduced pulmonary function in type 2 diabetes: the Fremantle Diabetes Study. Diabetes Care. 2004 Mar;27(3):752-7. doi: 10.2337/diacare.27.3.752.

  PMID: 14988297 BACKGROUND

• Nicolaie T, Zavoianu C, Nuta P. Pulmonary involvement in diabetes mellitus. Rom J Intern Med. 2003;41(4):365-74.

  PMID: 15526520 BACKGROUND

• Lopez-Cano C, Ciudin A, Sanchez E, Tinahones FJ, Barbe F, Dalmases M, Garcia-Ramirez M, Soto A, Gaeta AM, Pellitero S, Marti R, Hernandez C, Simo R, Lecube A. Liraglutide Improves Forced Vital Capacity in Individuals With Type 2 Diabetes: Data From the Randomized Crossover LIRALUNG Study. Diabetes. 2022 Feb 1;71(2):315-320. doi: 10.2337/db21-0688.

  PMID: 34737187 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Anna Royo
• Organization: Dynamic Science S.L

a.royo@dynasolutions.com

+34680603119

Study Officials

• Albert Lecube, PhD

  Hospital Universitari Arnau de Vilanova de Lleida

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 5, 2016
• Study Start: October 4, 2016
• Primary Completion: November 18, 2019
• Study Completion: December 16, 2019
• Last Updated: February 26, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)