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Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus
Phase 3 trial testing liraglutide in Type 2 Diabetes in 76 participants. Completed in 16 December 2019.
| Lead sponsor | Lecube, Albert, M.D. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 4 October 2016 |
| Primary completion | 18 November 2019 |
| Estimated completion | 16 December 2019 |
| Sites | 6 locations across Spain |
Lecube, Albert, M.D.
Adults 40 to 65, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Liraglutide | 4.1 | 0.0 – 8.3 |
| Placebo | 4.3 | 0.1 – 8.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Liraglutide | 5.4 | 2.1 – 8.7 |
| Placebo | 0.2 | -2.5 – 3.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Liraglutide | 40.9 | 30.8 – 44.5 |
| Placebo | 41.3 | 21.5 – 50.3 |
| Group | Value | 95% CI |
|---|---|---|
| Liraglutide | 169.6 | 108.1 – 233.6 |
| Placebo | 201.5 | 115.3 – 284.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Liraglutide | 8.0 | -4.1 – 20.1 |
| Placebo | 12.5 | 2.2 – 22.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Liraglutide | -2.1 | -5.1 – 0.9 |
| Placebo | 1.7 | -0.8 – 4.2 |
Changes from baseline on measurements of respiratory function defined by residual volume (RV).
| Group | Value | 95% CI |
|---|---|---|
| Liraglutide | 3.2 | -17.5 – 24.1 |
| Placebo | -1.1 | -25.4 – 23.1 |
Changes from baseline on measurements of respiratory function defined by Total lung capacity (TLC).
| Group | Value | 95% CI |
|---|---|---|
| Liraglutide | -2.6 | -11.9 – 6.6 |
| Placebo | -3.1 | -9.5 – 3.2 |
Time frame: 7 weeks of treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Liraglutide | Placebo |
|---|---|---|---|
| Ischemic stroke | Vascular disorders | — | — |
| Reaction | System | Liraglutide | Placebo |
|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | — | — |
| Infections and infestations | Infections and infestations | — | — |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | — | — |
| Nervous system disorders | Nervous system disorders | — | — |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — | — |
| Renal and urinary disorders | Renal and urinary disorders | — | — |
| General disorders and administration site conditions | General disorders | — | — |
| Cardiac disorders | Cardiac disorders | — | — |
| Traumatic injuries, poisonings and complications of therapeutic procedures | Injury, poisoning and procedural complications | — | — |
| Congenital, family and genetic disorders | Congenital, familial and genetic disorders | — | — |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Ischemic stroke.
Data from ClinicalTrials.gov NCT02889510 adverse events section.
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
3 peer-reviewed publications reference this trial (live from Europe PMC):
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