NCT02851745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
Last Updated

May 25, 2021

Status Verified

July 1, 2019

Enrollment Period

4 years

First QC Date

July 28, 2016

Last Update Submit

May 21, 2021

Conditions

Diabetes Mellitus, Type 2Left Ventricular Systolic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes in diastolic LV function

    48 weeks

Study Arms (2)

Linagliptin

EXPERIMENTAL

Linagliptin 5 mg daily for 48 weeks

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

Placebo 5 mg daily for 48 weeks

Drug: Placebo

Interventions

LinagliptinDRUG
Also known as: Trajenta
Linagliptin
PlaceboDRUG
Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Azienda Ospedaliera Papa Giovanni Xxiii

Bergamo, BG, 24127, Italy

Location

P.O. Garibaldi-Nesima

Catania, CT, 95122, Italy

Location

Ospedale Casa Sollievo Della Sofferenza

San Giovanni Rotondo, FG, 71013, Italy

Location

Ospedale Villa Scassi

Genova, GE, 16149, Italy

Location

Iclas-Istituto Clinico Ligure Alta Spec.

Rapallo, GE, 16035, Italy

Location

Ospedale San Giuseppe Da Copertino

Copertino, LE, 73043, Italy

Location

Ospedale San Raffaele

Milan, Lombardy, 20010, Italy

Location

Policlinico G. Martino

Messina, ME, 98124, Italy

Location

Irccs Policlinico Multimedica

Sesto San Giovanni, MI, 20099, Italy

Location

A.O. Santa Croce e Carle

Cuneo, Piedmont, 12100, Italy

Location

Ospedale Sandro Pertini

Roma, RM, 00157, Italy

Location

Ospedale Maggiore

Chieri, TO, 10023, Italy

Location

Ospedale Mauriziano

Torino, TO, 10128, Italy

Location

Azienda Ospedaliera Santa Maria

Terni, TR, 05100, Italy

Location

Aas 1 Triestina

Trieste, TS, 34148, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Aorn Osp. Dei Colli- Po Vincenzo Monaldi

Napoli, 80131, Italy

Location

Seconda Universita' Di Napoli

Napoli, 80131, Italy

Location

Casa di Cura Villa Bianca

Trento, 38100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 31418140BACKGROUND

  • 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.

    PMID: 33755143RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Ventricular Dysfunction, Left

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Carlo B. Giorda, MD

    Ospedale Maggiore - Diabetologia Malattie Metaboliche - Chieri

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 2, 2016

Study Start

July 1, 2015

Primary Completion

July 2, 2019

Study Completion

July 2, 2019

Last Updated

May 25, 2021

Record last verified: 2019-07

Locations

IT(19)