Effects of Linagliptin on Left Ventricular Myocardial DYsfunction in Patients With Type 2 DiAbetes Mellitus and Concentric Left Ventricular Geometry (DYDA2)
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|ClinicalTrials.gov Identifier: NCT02851745|
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Left Ventricular Systolic Dysfunction||Drug: Linagliptin Drug: Placebo||Phase 3|
Multicentre, randomized, double blind, parallel group comparison of an DPP-4 inhibitor, linagliptin 5 mg od, versus placebo (1:1) in patients with T2DM and a documented baseline concentric LV geometry and LV systolic dysfunction.
The management of glycemia will be left to the Investigator's judgment informed by clinical guidelines. The Investigator will therefore be allowed to undertake appropriate action, i.e.:
- Adjust the background antidiabetic treatment.
- Prescribe an additional antidiabetic medication according to its labeling (with the exclusion of other DPP-4 inhibitor or GLP-1 receptor agonist).
The enrollment period will last 12 months. The patients will be followed up for 48 weeks from randomization.
After the randomization the patients will have a control visit after 2 weeks (Visit 3) and at 3 months from randomization (Visit 4, week 12). At Visit 4 blood samples will be collected.
Afterwards the patients will have one control visit at 24 weeks from randomization (Visit 5) and a final visit at 48 weeks from randomization (Visit 6) with echocardiogram and ECG performed and blood samples collected.
Patients still on study treatment at the time of final visit (Visit 6) will have a post treatment safety follow up (clinical visit or phone contact) 30 days after the study treatment discontinuation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of the Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Linagliptin on Left Ventricular Myocardial DYsfunction in Patients With Type 2 DiAbetes Mellitus and Concentric Left Ventricular Geometry|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||July 2, 2019|
|Actual Study Completion Date :||July 2, 2019|
Linagliptin 5 mg daily for 48 weeks
Other Name: Trajenta
Placebo Comparator: Placebo
Placebo 5 mg daily for 48 weeks
- Increase in LV systolic function [ Time Frame: 48 weeks ]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).
- Changes in diastolic LV function [ Time Frame: 48 weeks ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851745
|Azienda Ospedaliera Papa Giovanni Xxiii|
|Bergamo, BG, Italy, 24127|
|Catania, CT, Italy, 95122|
|Ospedale Casa Sollievo Della Sofferenza|
|San Giovanni Rotondo, FG, Italy, 71013|
|Ospedale Villa Scassi|
|Genova, GE, Italy, 16149|
|Iclas-Istituto Clinico Ligure Alta Spec.|
|Rapallo, GE, Italy, 16035|
|Ospedale San Giuseppe Da Copertino|
|Copertino, LE, Italy, 73043|
|Ospedale San Raffaele|
|Milano, Lombardia, Italy, 20010|
|Policlinico G. Martino|
|Messina, ME, Italy, 98124|
|Irccs Policlinico Multimedica|
|Sesto San Giovanni, MI, Italy, 20099|
|A.O. Santa Croce e Carle|
|Cuneo, Piemonte, Italy, 12100|
|Ospedale Sandro Pertini|
|Roma, RM, Italy, 00157|
|Chieri, TO, Italy, 10023|
|Torino, TO, Italy, 10128|
|Azienda Ospedaliera Santa Maria|
|Terni, TR, Italy, 05100|
|Aas 1 Triestina|
|Trieste, TS, Italy, 34148|
|Centro Cardiologico Monzino|
|Milano, Italy, 20138|
|Aorn Osp. Dei Colli- Po Vincenzo Monaldi|
|Napoli, Italy, 80131|
|Seconda Universita' Di Napoli|
|Napoli, Italy, 80131|
|Casa di Cura Villa Bianca|
|Trento, Italy, 38100|
|Study Chair:||Carlo B. Giorda, MD||Ospedale Maggiore - Diabetologia Malattie Metaboliche - Chieri|