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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT02889510 (opens ClinicalTrials.gov in a new tab)Other idLIRALUNG
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
76 participants (actual)
Sponsor
Lecube, Albert, M.D. · Indiv
Design
Randomized · Double masking
Countries
1 country

Spain

Start
4 Oct 2016
Primary completion
18 Nov 2019
Completion
16 Dec 2019
First posted
5 Sept 2016 (estimated)
Last update posted
26 Feb 2021
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 3

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

    NCT02889510

    4 Oct 2016 to 16 Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Other

    liraglutide

    7-week subcutaneous liraglutide treatment once daily

  • Other

    placebo

    7-week subcutaneous placebo treatment once daily.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 7 weeks

    Registry description

    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.

Secondary outcomes(7)

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

    Time frame · 7 weeks

    Registry description

    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.

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

    Time frame · 7 weeks

    Registry description

    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.

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

    Time frame · 7 weeks

    Registry description

    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.

  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

    Registry description

    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.

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

    Time frame · 7 weeks

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 7 weeks

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

GroupValue (% (FEV1))
Liraglutide4.1
Placebo4.3
Secondary and other outcome results(7)
Secondary outcomeMean· 7 weeks

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

GroupValue (% (FVC))
Liraglutide5.4
Placebo0.2
Secondary outcomeMedian· 7 weeks

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

GroupValue (ng/ml)
Liraglutide40.9
Placebo41.3
Secondary outcomeMean· 7 weeks

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

GroupValue (% (FEF25-75))
Liraglutide8.0
Placebo12.5
Secondary outcomeMean· 7 weeks

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

GroupValue (% (FEV1/FVC))
Liraglutide-2.1
Placebo1.7
Secondary outcomeMean· 7 weeks

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

GroupValue (% (RV))
Liraglutide3.2
Placebo-1.1
Secondary outcomeMean· 7 weeks

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

GroupValue (% (TLCO))
Liraglutide-2.6
Placebo-3.1
Secondary outcome· 7 weeks

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

GroupValue
Liraglutidenot posted
Placebonot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide7-week subcutaneous liraglutide treatment once daily liraglutide: 7-week subcutaneous liraglutide once daily0 / 700 / 7019 / 70
Placebo7-week subcutaneous placebo treatment once daily. placebo: 7-week subcutaneous placebo once daily0 / 701 / 7013 / 70

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

5 results

Liraglutide Improves Forced Vital Capacity in Individuals With Type 2 Diabetes: Data From the Randomized Crossover LIRALUNG Study.

López-Cano et al. 2022Diabetescited by 40

PMID 34737187DOI 10.2337/db21-0688PUB-34737187

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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