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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
Sponsor:
Collaborator:
Fondazione dell’Associazione Medici Diabetologi
Information provided by (Responsible Party):
Heart Care Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Left Ventricular Systolic Dysfunction Drug: Linagliptin Drug: Placebo Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: Linagliptin
Linagliptin 5 mg daily for 48 weeks
Drug: Linagliptin
Other Name: Trajenta

Placebo Comparator: Placebo
Placebo 5 mg daily for 48 weeks
Drug: Placebo



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

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


Locations
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Italy
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, BG, Italy, 24127
P.O. Garibaldi-Nesima
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
Ospedale Maggiore
Chieri, TO, Italy, 10023
Ospedale Mauriziano
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
Sponsors and Collaborators
Heart Care Foundation
Fondazione dell’Associazione Medici Diabetologi
Investigators
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Study Chair: Carlo B. Giorda, MD Ospedale Maggiore - Diabetologia Malattie Metaboliche - Chieri

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heart Care Foundation
ClinicalTrials.gov Identifier: NCT02851745     History of Changes
Other Study ID Numbers: G113
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action