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
Purpose A multicentre, randomized, double-blind, placebo-controlled, parallel-group study aimed to define the potential positive effect of dipeptidyl peptidase-4 inhibition on left ventricular systolic function (LVSF) beyond glycemic control in type 2 diabetes mellitus (T2DM) (DYDA 2™ trial). Method...
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| Veröffentlicht in: | Cardiovascular drugs and therapy 2019-10, Vol.33 (5), p.547-555 |
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| creator | Giorda, Carlo Bruno Cioffi, Giovanni Lucci, Donata Nada, Elisa Ognibeni, Federica Mancusi, Costantino Latini, Roberto Maggioni, Aldo P. |
| description | Purpose
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study aimed to define the potential positive effect of dipeptidyl peptidase-4 inhibition on left ventricular systolic function (LVSF) beyond glycemic control in type 2 diabetes mellitus (T2DM) (DYDA 2™ trial).
Methods
Individuals with fairly controlled T2DM and asymptomatic impaired LVSF were randomized in a 1:1 ratio to receive for 48 weeks either linagliptin 5 mg daily or placebo, in addition to their stable diabetes therapy. Eligibility criteria were age ≥ 40 years, history of T2DM with a duration of at least 6 months, HbA1c ≤ 8.0% (≤ 64 mmol/mol), no history or clinical signs/symptoms of cardiac disease, evidence at baseline echocardiography of concentric LV geometry (relative wall thickness ≥ 0.42), and impaired LVSF defined as midwall fractional shortening (MFS) ≤ 15%. The primary end-point was the modification from baseline to 48 weeks of MFS. As an exploratory analysis, significant changes in LV global longitudinal strain and global circumferential strain, measured by speckle tracking echocardiography, were also considered. Secondary objectives were changes in diastolic and/or in systolic longitudinal function as measured by tissue Doppler.
Results
A total of 188 patients were enrolled. They were predominantly males, mildly obese, with typical insulin-resistance co-morbidities such as hypertension and dyslipidemia. Mean relative wall thickness was 0.51 ± 0.09 and mean MFS 13.3% ± 2.5.
Conclusions
DYDA 2 is the first randomized, double-blind, placebo-controlled trial to explore the effect of a dipeptidyl peptidase-4 inhibitor on LVSF in T2DM patients in primary prevention regardless of glycemic control. The main characteristics of the enrolled population are reported.
Trial registration
ClinicalTrial.gov
Identifier: NCT02851745. |
| doi_str_mv | 10.1007/s10557-019-06898-6 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2275261492</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2275261492</sourcerecordid><originalsourceid>FETCH-LOGICAL-c2906-9bca4547815ef4e514029de65f897784c6b0d9a37859b9c3e38b42b21bfed0d73</originalsourceid><addsrcrecordid>eNp9kt-K1DAUxqso7rj6Al7IAW9W2K5J-jeX68y6Lgw46Ch4VdL0dCZLJ6lJivTeJ_HRfBIz7aqg4FUC5_d9X074ougZJReUkOKVoyTLiphQHpO85GWc348WNCuSuGApfRAtCGckThjJT6LHzt2SIOK8fBSdJDSlJU3J4l501bYovQPTwkr12HvVjB1spotwGKdwo_eqVt5YWCstdp0KIw1GwxpbD59Qe6vk0AkLq9G1g5ZehWFANsKrMHXwVfk9bMcegYUQUaNHB0I3sDRazvp_za7RHNDbEc78HmH1eXUJ7Me377C1SnQvL-C9OOaIDs9hhU7t9Plk-To8ulMaYbkXVkiPVjmv5LTg0eiDH5oRNqYPIUeDJ9HDVnQOn96dp9HHN1fb5dt4_e76Znm5jiXjJI95LUWapUVJM2xTzMLnMd5gnrUlL4oylXlNGi6Sosx4zWWCSVmnrGa0brEhTZGcRmezb2_NlwGdrw7KSew6odEMrmKsyFhOU84C-uIv9NYMNqw6UUlOQh4JFJspaY1zFtuqt-og7FhRUh37Uc39qEI_qqkfVR5Ez--sh_qAzW_Jr0IEIJkBF0Z6h_ZP9n9sfwLco8jT</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2273607840</pqid></control><display><type>article</type><title>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</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Giorda, Carlo Bruno ; Cioffi, Giovanni ; Lucci, Donata ; Nada, Elisa ; Ognibeni, Federica ; Mancusi, Costantino ; Latini, Roberto ; Maggioni, Aldo P.</creator><creatorcontrib>Giorda, Carlo Bruno ; Cioffi, Giovanni ; Lucci, Donata ; Nada, Elisa ; Ognibeni, Federica ; Mancusi, Costantino ; Latini, Roberto ; Maggioni, Aldo P. ; DYDA 2 Investigators ; on behalf of DYDA 2 Investigators</creatorcontrib><description>Purpose
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study aimed to define the potential positive effect of dipeptidyl peptidase-4 inhibition on left ventricular systolic function (LVSF) beyond glycemic control in type 2 diabetes mellitus (T2DM) (DYDA 2™ trial).
Methods
Individuals with fairly controlled T2DM and asymptomatic impaired LVSF were randomized in a 1:1 ratio to receive for 48 weeks either linagliptin 5 mg daily or placebo, in addition to their stable diabetes therapy. Eligibility criteria were age ≥ 40 years, history of T2DM with a duration of at least 6 months, HbA1c ≤ 8.0% (≤ 64 mmol/mol), no history or clinical signs/symptoms of cardiac disease, evidence at baseline echocardiography of concentric LV geometry (relative wall thickness ≥ 0.42), and impaired LVSF defined as midwall fractional shortening (MFS) ≤ 15%. The primary end-point was the modification from baseline to 48 weeks of MFS. As an exploratory analysis, significant changes in LV global longitudinal strain and global circumferential strain, measured by speckle tracking echocardiography, were also considered. Secondary objectives were changes in diastolic and/or in systolic longitudinal function as measured by tissue Doppler.
Results
A total of 188 patients were enrolled. They were predominantly males, mildly obese, with typical insulin-resistance co-morbidities such as hypertension and dyslipidemia. Mean relative wall thickness was 0.51 ± 0.09 and mean MFS 13.3% ± 2.5.
Conclusions
DYDA 2 is the first randomized, double-blind, placebo-controlled trial to explore the effect of a dipeptidyl peptidase-4 inhibitor on LVSF in T2DM patients in primary prevention regardless of glycemic control. The main characteristics of the enrolled population are reported.
Trial registration
ClinicalTrial.gov
Identifier: NCT02851745.</description><identifier>ISSN: 0920-3206</identifier><identifier>EISSN: 1573-7241</identifier><identifier>DOI: 10.1007/s10557-019-06898-6</identifier><identifier>PMID: 31418140</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Aged ; Biomarkers - blood ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; Cardiology ; Clinical trials ; Control methods ; Coronary artery disease ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - diagnosis ; Diabetes Mellitus, Type 2 - drug therapy ; Dipeptidyl-peptidase IV ; Dipeptidyl-Peptidase IV Inhibitors - adverse effects ; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use ; Double-Blind Method ; Dyslipidemia ; Echocardiography ; Female ; Glycated Hemoglobin A - metabolism ; Heart diseases ; Humans ; Hypertension ; Inhibitors ; Insulin ; Italy ; Linagliptin - adverse effects ; Linagliptin - therapeutic use ; Longitude ; Male ; Males ; Medicine ; Medicine & Public Health ; Middle Aged ; Multicenter Studies as Topic ; Original Article ; Peptidase ; Population studies ; Randomization ; Randomized Controlled Trials as Topic ; Signs and symptoms ; Time Factors ; Treatment Outcome ; Ventricle ; Ventricular Dysfunction, Left - diagnostic imaging ; Ventricular Dysfunction, Left - drug therapy ; Ventricular Dysfunction, Left - physiopathology ; Ventricular Function, Left - drug effects ; Ventricular Remodeling - drug effects ; Wall thickness</subject><ispartof>Cardiovascular drugs and therapy, 2019-10, Vol.33 (5), p.547-555</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2019</rights><rights>Cardiovascular Drugs and Therapy is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2906-9bca4547815ef4e514029de65f897784c6b0d9a37859b9c3e38b42b21bfed0d73</citedby><cites>FETCH-LOGICAL-c2906-9bca4547815ef4e514029de65f897784c6b0d9a37859b9c3e38b42b21bfed0d73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10557-019-06898-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10557-019-06898-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31418140$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Giorda, Carlo Bruno</creatorcontrib><creatorcontrib>Cioffi, Giovanni</creatorcontrib><creatorcontrib>Lucci, Donata</creatorcontrib><creatorcontrib>Nada, Elisa</creatorcontrib><creatorcontrib>Ognibeni, Federica</creatorcontrib><creatorcontrib>Mancusi, Costantino</creatorcontrib><creatorcontrib>Latini, Roberto</creatorcontrib><creatorcontrib>Maggioni, Aldo P.</creatorcontrib><creatorcontrib>DYDA 2 Investigators</creatorcontrib><creatorcontrib>on behalf of DYDA 2 Investigators</creatorcontrib><title>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</title><title>Cardiovascular drugs and therapy</title><addtitle>Cardiovasc Drugs Ther</addtitle><addtitle>Cardiovasc Drugs Ther</addtitle><description>Purpose
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study aimed to define the potential positive effect of dipeptidyl peptidase-4 inhibition on left ventricular systolic function (LVSF) beyond glycemic control in type 2 diabetes mellitus (T2DM) (DYDA 2™ trial).
Methods
Individuals with fairly controlled T2DM and asymptomatic impaired LVSF were randomized in a 1:1 ratio to receive for 48 weeks either linagliptin 5 mg daily or placebo, in addition to their stable diabetes therapy. Eligibility criteria were age ≥ 40 years, history of T2DM with a duration of at least 6 months, HbA1c ≤ 8.0% (≤ 64 mmol/mol), no history or clinical signs/symptoms of cardiac disease, evidence at baseline echocardiography of concentric LV geometry (relative wall thickness ≥ 0.42), and impaired LVSF defined as midwall fractional shortening (MFS) ≤ 15%. The primary end-point was the modification from baseline to 48 weeks of MFS. As an exploratory analysis, significant changes in LV global longitudinal strain and global circumferential strain, measured by speckle tracking echocardiography, were also considered. Secondary objectives were changes in diastolic and/or in systolic longitudinal function as measured by tissue Doppler.
Results
A total of 188 patients were enrolled. They were predominantly males, mildly obese, with typical insulin-resistance co-morbidities such as hypertension and dyslipidemia. Mean relative wall thickness was 0.51 ± 0.09 and mean MFS 13.3% ± 2.5.
Conclusions
DYDA 2 is the first randomized, double-blind, placebo-controlled trial to explore the effect of a dipeptidyl peptidase-4 inhibitor on LVSF in T2DM patients in primary prevention regardless of glycemic control. The main characteristics of the enrolled population are reported.
Trial registration
ClinicalTrial.gov
Identifier: NCT02851745.</description><subject>Adult</subject><subject>Aged</subject><subject>Biomarkers - blood</subject><subject>Blood Glucose - drug effects</subject><subject>Blood Glucose - metabolism</subject><subject>Cardiology</subject><subject>Clinical trials</subject><subject>Control methods</subject><subject>Coronary artery disease</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - diagnosis</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Dipeptidyl-peptidase IV</subject><subject>Dipeptidyl-Peptidase IV Inhibitors - adverse effects</subject><subject>Dipeptidyl-Peptidase IV Inhibitors - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Dyslipidemia</subject><subject>Echocardiography</subject><subject>Female</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Heart diseases</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Inhibitors</subject><subject>Insulin</subject><subject>Italy</subject><subject>Linagliptin - adverse effects</subject><subject>Linagliptin - therapeutic use</subject><subject>Longitude</subject><subject>Male</subject><subject>Males</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Multicenter Studies as Topic</subject><subject>Original Article</subject><subject>Peptidase</subject><subject>Population studies</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Signs and symptoms</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Ventricle</subject><subject>Ventricular Dysfunction, Left - diagnostic imaging</subject><subject>Ventricular Dysfunction, Left - drug therapy</subject><subject>Ventricular Dysfunction, Left - physiopathology</subject><subject>Ventricular Function, Left - drug effects</subject><subject>Ventricular Remodeling - drug effects</subject><subject>Wall thickness</subject><issn>0920-3206</issn><issn>1573-7241</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kt-K1DAUxqso7rj6Al7IAW9W2K5J-jeX68y6Lgw46Ch4VdL0dCZLJ6lJivTeJ_HRfBIz7aqg4FUC5_d9X074ougZJReUkOKVoyTLiphQHpO85GWc348WNCuSuGApfRAtCGckThjJT6LHzt2SIOK8fBSdJDSlJU3J4l501bYovQPTwkr12HvVjB1spotwGKdwo_eqVt5YWCstdp0KIw1GwxpbD59Qe6vk0AkLq9G1g5ZehWFANsKrMHXwVfk9bMcegYUQUaNHB0I3sDRazvp_za7RHNDbEc78HmH1eXUJ7Me377C1SnQvL-C9OOaIDs9hhU7t9Plk-To8ulMaYbkXVkiPVjmv5LTg0eiDH5oRNqYPIUeDJ9HDVnQOn96dp9HHN1fb5dt4_e76Znm5jiXjJI95LUWapUVJM2xTzMLnMd5gnrUlL4oylXlNGi6Sosx4zWWCSVmnrGa0brEhTZGcRmezb2_NlwGdrw7KSew6odEMrmKsyFhOU84C-uIv9NYMNqw6UUlOQh4JFJspaY1zFtuqt-og7FhRUh37Uc39qEI_qqkfVR5Ez--sh_qAzW_Jr0IEIJkBF0Z6h_ZP9n9sfwLco8jT</recordid><startdate>20191001</startdate><enddate>20191001</enddate><creator>Giorda, Carlo Bruno</creator><creator>Cioffi, Giovanni</creator><creator>Lucci, Donata</creator><creator>Nada, Elisa</creator><creator>Ognibeni, Federica</creator><creator>Mancusi, Costantino</creator><creator>Latini, Roberto</creator><creator>Maggioni, Aldo P.</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20191001</creationdate><title>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</title><author>Giorda, Carlo Bruno ; Cioffi, Giovanni ; Lucci, Donata ; Nada, Elisa ; Ognibeni, Federica ; Mancusi, Costantino ; Latini, Roberto ; Maggioni, Aldo P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2906-9bca4547815ef4e514029de65f897784c6b0d9a37859b9c3e38b42b21bfed0d73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biomarkers - blood</topic><topic>Blood Glucose - drug effects</topic><topic>Blood Glucose - metabolism</topic><topic>Cardiology</topic><topic>Clinical trials</topic><topic>Control methods</topic><topic>Coronary artery disease</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - diagnosis</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Dipeptidyl-peptidase IV</topic><topic>Dipeptidyl-Peptidase IV Inhibitors - adverse effects</topic><topic>Dipeptidyl-Peptidase IV Inhibitors - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Dyslipidemia</topic><topic>Echocardiography</topic><topic>Female</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Heart diseases</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Inhibitors</topic><topic>Insulin</topic><topic>Italy</topic><topic>Linagliptin - adverse effects</topic><topic>Linagliptin - therapeutic use</topic><topic>Longitude</topic><topic>Male</topic><topic>Males</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Multicenter Studies as Topic</topic><topic>Original Article</topic><topic>Peptidase</topic><topic>Population studies</topic><topic>Randomization</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Signs and symptoms</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Ventricle</topic><topic>Ventricular Dysfunction, Left - diagnostic imaging</topic><topic>Ventricular Dysfunction, Left - drug therapy</topic><topic>Ventricular Dysfunction, Left - physiopathology</topic><topic>Ventricular Function, Left - drug effects</topic><topic>Ventricular Remodeling - drug effects</topic><topic>Wall thickness</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Giorda, Carlo Bruno</creatorcontrib><creatorcontrib>Cioffi, Giovanni</creatorcontrib><creatorcontrib>Lucci, Donata</creatorcontrib><creatorcontrib>Nada, Elisa</creatorcontrib><creatorcontrib>Ognibeni, Federica</creatorcontrib><creatorcontrib>Mancusi, Costantino</creatorcontrib><creatorcontrib>Latini, Roberto</creatorcontrib><creatorcontrib>Maggioni, Aldo P.</creatorcontrib><creatorcontrib>DYDA 2 Investigators</creatorcontrib><creatorcontrib>on behalf of DYDA 2 Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Complete (ProQuest Database)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Cardiovascular drugs and therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Giorda, Carlo Bruno</au><au>Cioffi, Giovanni</au><au>Lucci, Donata</au><au>Nada, Elisa</au><au>Ognibeni, Federica</au><au>Mancusi, Costantino</au><au>Latini, Roberto</au><au>Maggioni, Aldo P.</au><aucorp>DYDA 2 Investigators</aucorp><aucorp>on behalf of DYDA 2 Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Cardiovascular drugs and therapy</jtitle><stitle>Cardiovasc Drugs Ther</stitle><addtitle>Cardiovasc Drugs Ther</addtitle><date>2019-10-01</date><risdate>2019</risdate><volume>33</volume><issue>5</issue><spage>547</spage><epage>555</epage><pages>547-555</pages><issn>0920-3206</issn><eissn>1573-7241</eissn><abstract>Purpose
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study aimed to define the potential positive effect of dipeptidyl peptidase-4 inhibition on left ventricular systolic function (LVSF) beyond glycemic control in type 2 diabetes mellitus (T2DM) (DYDA 2™ trial).
Methods
Individuals with fairly controlled T2DM and asymptomatic impaired LVSF were randomized in a 1:1 ratio to receive for 48 weeks either linagliptin 5 mg daily or placebo, in addition to their stable diabetes therapy. Eligibility criteria were age ≥ 40 years, history of T2DM with a duration of at least 6 months, HbA1c ≤ 8.0% (≤ 64 mmol/mol), no history or clinical signs/symptoms of cardiac disease, evidence at baseline echocardiography of concentric LV geometry (relative wall thickness ≥ 0.42), and impaired LVSF defined as midwall fractional shortening (MFS) ≤ 15%. The primary end-point was the modification from baseline to 48 weeks of MFS. As an exploratory analysis, significant changes in LV global longitudinal strain and global circumferential strain, measured by speckle tracking echocardiography, were also considered. Secondary objectives were changes in diastolic and/or in systolic longitudinal function as measured by tissue Doppler.
Results
A total of 188 patients were enrolled. They were predominantly males, mildly obese, with typical insulin-resistance co-morbidities such as hypertension and dyslipidemia. Mean relative wall thickness was 0.51 ± 0.09 and mean MFS 13.3% ± 2.5.
Conclusions
DYDA 2 is the first randomized, double-blind, placebo-controlled trial to explore the effect of a dipeptidyl peptidase-4 inhibitor on LVSF in T2DM patients in primary prevention regardless of glycemic control. The main characteristics of the enrolled population are reported.
Trial registration
ClinicalTrial.gov
Identifier: NCT02851745.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>31418140</pmid><doi>10.1007/s10557-019-06898-6</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Cardiovascular drugs and therapy, 2019-10, Vol.33 (5), p.547-555 |
| issn | 0920-3206 1573-7241 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2275261492 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Aged Biomarkers - blood Blood Glucose - drug effects Blood Glucose - metabolism Cardiology Clinical trials Control methods Coronary artery disease Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - diagnosis Diabetes Mellitus, Type 2 - drug therapy Dipeptidyl-peptidase IV Dipeptidyl-Peptidase IV Inhibitors - adverse effects Dipeptidyl-Peptidase IV Inhibitors - therapeutic use Double-Blind Method Dyslipidemia Echocardiography Female Glycated Hemoglobin A - metabolism Heart diseases Humans Hypertension Inhibitors Insulin Italy Linagliptin - adverse effects Linagliptin - therapeutic use Longitude Male Males Medicine Medicine & Public Health Middle Aged Multicenter Studies as Topic Original Article Peptidase Population studies Randomization Randomized Controlled Trials as Topic Signs and symptoms Time Factors Treatment Outcome Ventricle Ventricular Dysfunction, Left - diagnostic imaging Ventricular Dysfunction, Left - drug therapy Ventricular Dysfunction, Left - physiopathology Ventricular Function, Left - drug effects Ventricular Remodeling - drug effects Wall thickness |
| title | 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 |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-07T16%3A52%3A02IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effects%20of%20Dipeptidyl%20Peptidase-4%20Inhibitor%20Linagliptin%20on%20Left%20Ventricular%20Dysfunction%20in%20Patients%20with%20Type%202%20Diabetes%20and%20Concentric%20Left%20Ventricular%20Geometry%20(the%20DYDA%202%E2%84%A2%20Trial).%20Rationale,%20Design,%20and%20Baseline%20Characteristics%20of%20the%20Study%20Population&rft.jtitle=Cardiovascular%20drugs%20and%20therapy&rft.au=Giorda,%20Carlo%20Bruno&rft.aucorp=DYDA%202%20Investigators&rft.date=2019-10-01&rft.volume=33&rft.issue=5&rft.spage=547&rft.epage=555&rft.pages=547-555&rft.issn=0920-3206&rft.eissn=1573-7241&rft_id=info:doi/10.1007/s10557-019-06898-6&rft_dat=%3Cproquest_cross%3E2275261492%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2273607840&rft_id=info:pmid/31418140&rfr_iscdi=true |