Type 2 DiabetesPhase 3NCT02889510
Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing liraglutide in people with Type 2 Diabetes, run by Lecube, Albert, M.D. at 6 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 6 sitesSpain
- Study dates
- 4 Oct 2016to 16 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitari Vall d´Hebrón
Barcelona, 08035
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, 25198
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Virgen del Rocío
Seville, 41013
About this study
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)
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
Read the 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:
- - There is growing evidence to suggest an association between type 2 diabetes and impaired pulmonary function.
- - 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.
- - 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.
- Conditions
- Type 2 Diabetes
- Being tested
- liraglutide, placebo
- Keywords
- diabetes, liraglutide, lung function
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
7-week subcutaneous liraglutide once daily
placeboDrug
7-week subcutaneous placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| liraglutide | Other | 7-week subcutaneous liraglutide treatment once daily Receives: Drug: liraglutide |
| placebo | Other | 7-week subcutaneous placebo treatment once daily. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start4 Oct 2016
- Primary completion18 Nov 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lecube, Albert, M.D.
- Collaborators
- Dynamic Solutions, Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Albert Lecube, PhD, Study director, Hospital Universitari Arnau de Vilanova de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889510
- Sponsor's protocol ID
- LIRALUNG
- Status last verified
- Jan 2021
- First submitted
- 25 Aug 2016
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 10960726Yeh 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.
PubMed 18056886Vara 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.
PubMed 11282754Lecube 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.
PubMed 20882512Lecube 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.
PubMed 20217039Lecube 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.
PubMed 19262746Fernandez-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.
PubMed 18285549Mannino 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.
PubMed 18579551Davis 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.
PubMed 14988297Nicolaie T, Zavoianu C, Nuta P. Pulmonary involvement in diabetes mellitus. Rom J Intern Med. 2003;41(4):365-74.
PubMed 15526520Lopez-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.
PubMed 34737187
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02889510
- Acronym / sponsor ID
- LIRALUNG
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, liraglutide, lung function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Lecube, Albert, M.D.
- Collaborators
- Dynamic Solutions, Novo Nordisk A/S
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Posted 26 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- - There is growing evidence to suggest an association between type 2 diabetes and impaired pulmonary function.
- - 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.
- - 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liraglutide | Other | Drug: liraglutide7-week subcutaneous liraglutide treatment once daily |
| placebo | Other | Drug: placebo7-week subcutaneous placebo treatment once daily. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutide7-week subcutaneous liraglutide once daily | Drug | liraglutide |
| placebo7-week subcutaneous placebo once daily | Drug | placebo |
Primary outcome
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). Mean difference between 7 weeks after treatment visit and baseline visit is registered.
7 secondary outcomes
Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC)
Time frame: 7 weeks
Changes From Baseline in Serum Levels of Surfactant A and D Protein
Time frame: 7 weeks
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 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 Residual Volume (RV)
Time frame: 7 weeks
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 Residual Functional Capacity (RFC)
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10960726Davis 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.
- Background: PubMed 18056886Yeh 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.
- Background: PubMed 11282754Vara 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.
- Background: PubMed 20882512Lecube 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.
- Background: PubMed 20217039Lecube 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.
- Background: PubMed 19262746Lecube 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.
- Background: PubMed 18285549Fernandez-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.
- Background: PubMed 18579551Mannino 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.
- Background: PubMed 14988297Davis 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.
- Background: PubMed 15526520Nicolaie T, Zavoianu C, Nuta P. Pulmonary involvement in diabetes mellitus. Rom J Intern Med. 2003;41(4):365-74.
- Derived from this study: PubMed 34737187Lopez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Lecube, PhD study director
Hospital Universitari Arnau de Vilanova de Lleida
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing liraglutide in people with Type 2 Diabetes, run by Lecube, Albert, M.D. at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1) (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889510, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.