Effects of linagliptin on left ventricular myocardial DYsfunction in patients with type 2 DiAbetes mellitus.

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. - DYDA 2 Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004683-38-IT

Enrollment

186

Registered

2014-12-03

Start date

2015-01-26

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes mellitus MedDRA version: 17.1 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 17.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 - Metabolis

Interventions

Trade Name: Trajenta Product Name: Trajenta Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Men and women aged equal to or more than 40 years at screening. • Patients with history of T2DM lasting at least six month prior to the screening visit. • HbA1c = 8.0% (= 64 mmol/mol) at screening. • Evidence of sinus rhythm at screening ECG evaluation • No clinical signs/symptoms of a cardiac disease and no evidence of coronary artery disease on the basis of clinical, electrocardiographic and echocardiographic evaluation at screening. • Evidence at baseline echocardiographic examination of concentric left ventricular geometry, defined as relative wall thickness = 0.42. Relative wall thickness was calculated as the end-diastolic ratio 2* posterior wall thickness/LV diameter. • Evidence at baseline echocardiographic examination of LV systolic dysfunction defined as Midwall shortening (MFS) =15% • Obtained informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: • Patients with a confirmed indication for an incretin treatment • Uncontrolled diabetes: HbA1c >8.0% (> 64 mmol/mol) or Fasting Plasma Glucose > 300 mg/dL measured at screening visit. • Glitazones within the last three months • Permanent atrial fibrillation • Uncontrolled hypertension (defined as systolic blood pressure>160 and/or diastolic blood pressure >90) • Unstable dosage and changes in type of antihypertensive, lipid lowering and antidiabetic drugs within 4 weeks before the screening visit. • Severe chronic renal dysfunction (defined as estimated glomerular filtration rate < 30 ml/min/1.73 m2). • Previous or current documented history of untreated (by using CPAP) obstructive sleep apnea syndrome • Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis. • Previous or current documented history of malignant disease • Pregnancy and breast feeding • Documented alcohol and drug abuse • Anticipated poor compliance • Current participation in a clinical trial with other investigational products

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 1.Assessment of changes in diastolic LV function. Transmitral peak E wave (pulse Doppler) and early diastolic Tissue Doppler velocity of mitral annulus (E’) will be used to classify LV diastolic function together with other parameters (E/A ratio of transmitral flow, deceleration time of E, left atrial volume, pulmonary artery systolic pressure) in 4 degrees: normal, mild dysfunction, moderate dysfunction and severe dysfunction. Changes from baseline and 48-weeks evaluation will be analyzed. 2.Assessment of changes in LV systolic longitudinal function (measured by tissue Doppler technique) (peak systolic velocity of S’ wave of mitral annulus). Changes from baseline and 48-weeks evaluation will be analyzed. Incidence of patients who have an improvement in S’> 25% from baseline (comparison between treated and not treated group). ;Primary end point(s): Changes from baseline to 48-weeks of LV systolic function measured by midwall shortening analysis. ;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 1.Assessment of changes in diastolic LV function. Transmitral peak E wave (pulse Doppler) and early diastolic Tissue Doppler velocity of mitral annulus (E’) will be used to classify LV diastolic function together with other parameters (E/A ratio of transmitral flow, deceleration time of E, left atrial volume, pulmonary artery systolic pressure) in 4 degrees: normal, mild dysfunction, moderate dysfunction and severe dysfunction. Changes from baseline and 48-weeks evaluation will be analyzed. 2.Assessment of changes in LV systolic longitudinal function (measured by tissue Doppler technique) (peak systolic velocity of S’ wave of mitral annulus). Changes from baseline and 48-weeks evaluation will be analyzed. Incidence of patients who have an improvement in S’> 25% from baseline (comparison between treated and not treated group). ;Primary end point(s): Changes from baseline to 48-weeks of LV systolic function measured by midwall shortening analysis. ;Timepoint(s) of evaluation of this end point: 48 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - Changes from baseline to 48-weeks in diastolic LV function: Transmitral peak E wave (pulse Doppler) and early diastolic Tissue Doppler velocity of mitral annulus (E’) will be used to classify LV diastolic function together with other parameters (E/A ratio of transmitral flow, deceleration time of E, left atrial volume, pulmonary artery systolic pressure) in 4 degrees: normal, mild dysfunction, moderate dysfunction and severe dysfunction. - Changes from baseline to 48-weeks in LV systolic longitudinal function measured by tissue Doppler technique (peak systolic velocity of S’ wave of mitral annulus); Incidence of patients who have an improvement in S’> 25% from baseline. ;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Secondary end point(s): - Changes from baseline to 48-weeks in diastolic LV function: Transmitral peak E wave (pulse Doppler) and early diastolic Tissue Doppler velocity of mitral annulus (E’) will be used to classify LV diastolic function together with other parameters (E/A ratio of transmitral flow, deceleration time of E, left atrial volume, pulmonary artery systolic pressure) in 4 degrees: normal, mild dysfunction, moderate dysfunction and severe dysfunction. - Changes from baseline to 48-weeks in LV systolic longitudinal function measured by tissue Doppler technique (peak systolic velocity of S’ wave of mitral annulus); Incidence of patients who have an improvement in S’> 25% from baseline. ;Timepoint(s) of evaluation of this end point: 48 weeks

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Countries

Italy

Contacts

Public ContactCentro Studi ANMCO

Fondazione per il Tuo cuore onlus

centrostudi@anmco.it00390555101359

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026