Clinical Trial Details
| Trial ID: | L6765 |
| Source ID: | NCT02851745 |
| Associated Drug: | Linagliptin |
| Title: | Effects of Linagliptin on Left Ventricular Myocardial DYsfunction in Patients With Type 2 DiAbetes Mellitus and Concentric Left Ventricular Geometry |
| Acronym: | DYDA2 |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2|Left Ventricular Systolic Dysfunction |
| Interventions: | DRUG: Linagliptin|DRUG: Placebo |
| Outcome Measures: | Primary: Increase in LV systolic function, Statistically significant change (equivalent to an increase of 10%) from baseline to 48 weeks of LV systolic function measured by analysis of the MFS (centralized reading)., 48 weeks | Secondary: Changes in diastolic LV function, * Changes from baseline to 48 weeks of diastolic LV function (centralized reading) classified, in the two moments of evaluation, in 4 stages: normal, mild dysfunction, moderate and severe dysfunction. The efficacy of treatment will be evaluated both in terms of significant reduction of the parameter E / E 'expressed as a continuous variable and as entity improvement of dysfunction analyzed by degrees, as described above. * Changes from baseline to 48 weeks of longitudinal LV systolic function (centralized reading) measured by tissue Doppler (peak systolic velocity of the wave S 'mitral ring); percentage of patients showing an improvement of S '\> 25% from baseline., 48 weeks |
| Sponsor/Collaborators: | Sponsor: Heart Care Foundation | Collaborators: Fondazione dell'Associazione Medici Diabetologi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 188 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-07 |
| Completion Date: | 2019-07-02 |
| Results First Posted: | |
| Last Update Posted: | 2021-05-25 |
| Locations: | Azienda Ospedaliera Papa Giovanni Xxiii, Bergamo, BG, 24127, Italy|P.O. Garibaldi-Nesima, Catania, CT, 95122, Italy|Ospedale Casa Sollievo Della Sofferenza, San Giovanni Rotondo, FG, 71013, Italy|Ospedale Villa Scassi, Genova, GE, 16149, Italy|Iclas-Istituto Clinico Ligure Alta Spec., Rapallo, GE, 16035, Italy|Ospedale San Giuseppe Da Copertino, Copertino, LE, 73043, Italy|Ospedale San Raffaele, Milano, Lombardia, 20010, Italy|Policlinico G. Martino, Messina, ME, 98124, Italy|Irccs Policlinico Multimedica, Sesto San Giovanni, MI, 20099, Italy|A.O. Santa Croce e Carle, Cuneo, Piemonte, 12100, Italy|Ospedale Sandro Pertini, Roma, RM, 00157, Italy|Ospedale Maggiore, Chieri, TO, 10023, Italy|Ospedale Mauriziano, Torino, TO, 10128, Italy|Azienda Ospedaliera Santa Maria, Terni, TR, 05100, Italy|Aas 1 Triestina, Trieste, TS, 34148, Italy|Centro Cardiologico Monzino, Milano, 20138, Italy|Aorn Osp. Dei Colli- Po Vincenzo Monaldi, Napoli, 80131, Italy|Seconda Universita' Di Napoli, Napoli, 80131, Italy|Casa di Cura Villa Bianca, Trento, 38100, Italy |
| URL: | https://clinicaltrials.gov/show/NCT02851745 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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