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Trial record 42 of 396 for:    LIRAGLUTIDE

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

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ClinicalTrials.gov Identifier: NCT02889510
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Dynamic Solutions
Novo Nordisk A/S
Information provided by (Responsible Party):
Lecube, Albert, M.D.

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: liraglutide Drug: placebo Phase 3

Detailed Description:

There is growing evidence to suggest an association between type 2 diabetes and impaired pulmonary function. In this regard, several cross-sectional studies have appeared showing decreased indices of forced expiration, lung volume and diffusion capacity as the main lung dysfunctions detected in type 2 diabetic populations. In fact, diabetes is frequently co-morbid with chronic obstructive pulmonary disease, and data from the Atherosclerosis Risk in Communities Study showed a faster pulmonary function decline in type 2 diabetic patients than in other participants. This is important because the reduction of FEV1 has been demonstrated an independent cause of mortality in diabetic patients.

Interestingly, lung function measures start to decrease several years before the diagnosis of diabetes. In this regard an investigation found that insulin resistance is an independent determinant of pulmonary function in non-diabetic morbidly obese women. In addition, the results suggest that the metabolic pathways related to insulin resistance are crucial in initiating lung abnormalities in type 2 diabetic patients.

The reasons for the association between respiratory disease and diabetes are unclear. However, the relationship between type 2 diabetes and muscle strength, the impairment in lung elastic properties, and the presence of a low-grade chronic inflammation state are involved. In supporting these findings, thickening of the alveolar epithelia and pulmonary capillary basal lamina, fibrosis, centrilobular emphysema, and pulmonary microangiopathy have been detected in autopsies of diabetic patients. In addition, defects in the bronchiolar surfactant layer, which is involved in maintaining airway stability and diameter, may also be considered a contributing factor to the impairment of airway calibre regulation in diabetic patients. When the alveolocapillary barrier is damaged, surfactant proteins leak into the bloodstream. A recent population-based random sample study has described how increased circulating levels of surfactant protein A, the major surfactant-associated protein, were associated with altered glucose tolerance and insulin resistance. Therefore, surfactant defects in diabetic individuals may also lead to an increase in airway resistance and to a reduction in ventilatory patterns as observed in our studies. In addition, as experimental studies have shown that glucagon-like peptide 1 plays a role in the stimulation of surfactant production, its underlying deficit in type 2 diabetes could also enhance the airway resistance observed in these patients. However, the beneficial effects on pulmonary function using incretin-based therapies remain to be elucidated.

Clinical trial study hypothesis is that treatment with an incretin mimetic such as liraglutide may ameliorate lung function parameters in type 2 diabetics patients, independently of weight reduction. This hypothesis is based on the following factors:

  1. - There is growing evidence to suggest an association between type 2 diabetes and impaired pulmonary function.
  2. - In patients with type 2 diabetes, the incretin effect is severely reduced or absent, contributing to the reduced lung function parameters observed in type 2 diabetic patients.
  3. - GLP-1 stimulates surfactant production in "in vitro" studies and, in consequence, the increase in surfactant production induced by liraglutide could be the main factor involved in the respiratory improvement.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
liraglutide
7-week subcutaneous liraglutide treatment once daily
Drug: liraglutide
7-week subcutaneous liraglutide once daily

placebo
7-week subcutaneous placebo treatment once daily.
Drug: placebo
7-week subcutaneous placebo once daily




Primary Outcome Measures :
  1. Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second (FEV1) [ Time Frame: 7 weeks ]
    Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second (FEV1)


Secondary Outcome Measures :
  1. Changes from baseline on measurements of respiratory function defined by forced vital capacity (FVC) [ Time Frame: 7 weeks ]
    Changes from baseline on measurements of respiratory function defined by forced vital capacity (FVC)

  2. Changes from baseline in serum levels of surfactant A and D protein. [ Time Frame: 7 weeks ]
    Changes from baseline in serum levels of surfactant A and D protein.

  3. Changes from baseline on measurements of respiratory function defined by Maximum mid-expiratory flow (FEF25-75) [ Time Frame: 7 weeks ]
    Changes from baseline on measurements of respiratory function defined by Maximum mid-expiratory flow (FEF25-75)

  4. 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 ]
    Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)

  5. Changes from baseline on measurements of respiratory function defined by residual volume (RV) [ Time Frame: 7 weeks ]
    Changes from baseline on measurements of respiratory function defined by residual volume (RV)

  6. Changes from baseline on measurements of respiratory function defined by Total lung capacity (TLC) [ Time Frame: 7 weeks ]
    Changes from baseline on measurements of respiratory function defined by Total lung capacity (TLC)

  7. Changes from baseline on measurements of respiratory function defined by Residual functional capacity (RFC) [ Time Frame: 7 weeks ]
    Changes from baseline on measurements of respiratory function defined by Residual functional capacity (RFC)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889510


Contacts
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Contact: Raúl Montalbán Casado +34 914561105 raul.m@dynasolutions.com
Contact: Liana De Plasencia +34 914561105 l.plasencia@dynasolutions.com

Locations
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Spain
Hospital Universitari Germans Trias i Pujol Not yet recruiting
Badalona, Barcelona, Spain, 08916
Contact: Manuel Puig-Domingo    +34 934978653    mpuig.germanstrias@gencat.cat   
Contact: Silvia Pellitero    +34 625391561    spellitero.germanstrias@gencat.cat   
Sub-Investigator: Silvia Pellitero         
Clínica Universidad de Navarra Not yet recruiting
Pamplona, Navarra, Spain, 31008
Contact: Javier Salvador    +34 660597980    jsalvador@unav.es   
Hospital Universitari Vall d´Hebrón Not yet recruiting
Barcelona, Spain, 08035
Contact: Rafael Simó       rafael.simo@vhir.org   
Contact: Lorena Ramos    +34 934894198    lorena.ramos@vhir.org   
Sub-Investigator: Andrea Ciudín         
Hospital Universitari Arnau de Vilanova de Lleida Recruiting
Lleida, Spain, 25198
Contact: Albert Lecube, PhD    +34 973705183    alecube@gmail.com   
Contact: Raquel Martí       rmarti@irblleida.cat   
Sub-Investigator: Carolina López         
Sub-Investigator: Cecilia Turino         
Sub-Investigator: Asunción Seminario         
Hospital Universitario Virgen de la Victoria Not yet recruiting
Málaga, Spain, 29010
Contact: Francisco Tinahones    +34 951034016    fjtinahones@hotmail.com   
Contact: Inmaculada Picón    +34 638430738    ipiconcesar@gmail.com   
Sub-Investigator: Baldomera Martínez         
Sub-Investigator: Paloma Romero         
Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41013
Contact: Pedro Pablo García    +34 607686901    garcialunapp@yahoo.es   
Sub-Investigator: Francisco Ortega         
Sub-Investigator: Antonio Jesús Martínez         
Sponsors and Collaborators
Lecube, Albert, M.D.
Dynamic Solutions
Novo Nordisk A/S
Investigators
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Study Director: Albert Lecube, PhD Hospital Universitari Arnau de Vilanova de Lleida

Publications:

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Responsible Party: Lecube, Albert, M.D.
ClinicalTrials.gov Identifier: NCT02889510     History of Changes
Other Study ID Numbers: LIRALUNG
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lecube, Albert, M.D.:
diabetes
liraglutide
lung function
Additional relevant MeSH terms:
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Liraglutide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists