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

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

It had two arms (groups): liraglutide (other) and placebo (other).

7-week subcutaneous liraglutide treatment once daily.

7-week subcutaneous placebo treatment once daily.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 76 actual participants took part.

It was open to people of any sex aged from 40 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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. BMI between 30 and 40 kg / m2. No pulmonary disease (COPD, asthma, fibrosis, etc) known.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: type 1 diabetes mellitus; treatment with inhibitors of dipeptidyl peptidase 4 glitazones and / or; SGLT2 inhibitors.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2016-10-04 with completion listed for 2019-11-18.

It ran at 6 sites in Spain (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1) (time frame: 7 weeks).

It also tracked 7 secondary outcomes, for example Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC), Changes From Baseline in Serum Levels of Surfactant A and D Protein, 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 Residual Volume (RV), Changes From Baseline on Measurements of Respiratory Function Defined by Total Lung Capacity (TLC) and Changes From Baseline on Measurements of Respiratory Function Defined by Residual Functional Capacity (RFC).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 76 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.