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| Name | Class |
|---|---|
| Fondazione dell'Associazione Medici Diabetologi | UNKNOWN |
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The primary objective of the study is to evaluate the effect of linagliptin 5 mg daily versus the corresponding placebo on the LV systolic function (measured by midwall shortening analysis) in patients with T2DM and a documented baseline concentric LV geometry and LV systolic dysfunction.
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.:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin | Experimental | Linagliptin 5 mg daily for 48 weeks |
|
| Placebo | Placebo Comparator | Placebo 5 mg daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in diastolic LV function |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo B. Giorda, MD | Ospedale Maggiore - Diabetologia Malattie Metaboliche - Chieri | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Papa Giovanni Xxiii | Bergamo | BG | 24127 | Italy | ||
| P.O. Garibaldi-Nesima |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31418140 | Background | Giorda CB, Cioffi G, Lucci D, Nada E, Ognibeni F, Mancusi C, Latini R, Maggioni AP; DYDA 2 Investigators. Effects of Dipeptidyl Peptidase-4 Inhibitor Linagliptin on Left Ventricular Dysfunction in Patients with Type 2 Diabetes and Concentric Left Ventricular Geometry (the DYDA 2 Trial). Rationale, Design, and Baseline Characteristics of the Study Population. Cardiovasc Drugs Ther. 2019 Oct;33(5):547-555. doi: 10.1007/s10557-019-06898-6. | |
| 33755143 |
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| Drug |
|
| 48 weeks |
| 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 | Milan | Lombardy | 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 | Piedmont | 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 | Milan | 20138 | Italy |
| Aorn Osp. Dei Colli- Po Vincenzo Monaldi | Naples | 80131 | Italy |
| Seconda Universita' Di Napoli | Naples | 80131 | Italy |
| Casa di Cura Villa Bianca | Trento | 38100 | Italy |
| Result |
| Cioffi G, Giorda CB, Lucci D, Nada E, Ognibeni F, Mancusi C, Latini R, Maggioni AP; DYDA 2 investigators. Effects of linagliptin on left ventricular DYsfunction in patients with type 2 DiAbetes and concentric left ventricular geometry: results of the DYDA 2 trial. Eur J Prev Cardiol. 2021 Mar 23;28(1):8-17. doi: 10.1177/2047487320939217. Epub 2020 Jul 28. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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