type 2 diabetes MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: JARDIANCE - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE
Product Name: JARDIANCE
Product Code: JARDIANCE
Pharmaceutical Form: Film-coated tablet
I
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male of female patients affected by type 2 diabetes mellitus (T2DM) • Subjects aged >40 and =65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: • Refuse to give or inability to give informed consent; • Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; • Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator; • Patients with type 1 diabetes mellitus; • Pregnancy or active breast feeding; • History of acute coronary syndrome; • Respiratory insufficiency or history of clinically significant respiratory diseases (chronic obstructive pulmonary disease); • Acute or chronic inflammatory diseases; • History of active neoplastic disease within the last 5 years; • Patients with known hypersensitivity to empagliflozin and its excipients; • Volume depleted patients or those who, in the judgement of the investigator, may be at risk for dehydration (abuse of diuretics or laxatives, chronic diarrhoea etc); • History of recurrent or serious genitor-urinary infections; • Patients with known hypersensitivity to sitagliptin and its excipients; • History of acute or chronic pancreatic disease; • Patients who received any investigational new drug within the last 12 weeks; • Severe obesity (BMI=40 kg/m2); • Uncontrolled blood pressure, defined as >160/100 mmHg; • eGFR3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN or total bilirubin >2.0 mg/dL; • Cardiac arrhythmia (2nd grade AV block, atrial fibrillation, peace maker, high incidence premature beats); • Clinically relevant cardiac valvular disease; • Ejection fraction <50% or presence of regional left ventricular contraction impairment; • Poor quality of echocardiographic imaging; • Inability to perform the cardiopulmonary exercise test; • Evidence of inducible myocardial ischemia at the cardiopulmonary test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify whether, in type 2 diabetic patients with normal 2-D ejection fraction (=50%) and without inducible myocardial ischemia at the cardiopulmonary test, the treatment with empagliflozin is associated with an improvement in left ventricular systolic function, as measured by global lungitudinal strain (GLS) through speckle tracking echography, in comparison to sitagliptin, an equally effective plasma glucose lowering agent, presumably neutral on cardiac function;Secondary Objective: ¿ Changes from baseline at 6 months after treatment initiation in HbA1c; ¿ Changes from baseline at 1 and 6 months after treatment initiation in other well established parameters of cardiac function, such as 3-D ejection fraction, left atrial volume, and E/E'. ¿ Changes from baseline at 6 months after treatment initiation in VO2 max (Cardiopulmonary exercise test), an extremely clinically relevant parameter that will help in appreciating the relevance of the imaging data. ;Primary end point(s): Changes in global longitudinal strain (GLS) from baseline to 1 month and 6 months after treatment initiation.;Timepoint(s) of evaluation of this end point: from baseline to 1 month and 6 months after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes from baseline at 6 months after treatment initiation in 1) HbA1c; 2) ejection fraction, left atrial volume and E/E', as measured at 3-D echocardiography; 3) VO2 max, as measured at cardiopulmonary test; 4) myocardial parietal stress plasma biomarker (BNP, NT-proBNP, proadrenomedullin), inflammation/oxidative stress plasma biomarkers (hsCRP, TNF-alpha, mieloperoxidase, uric acid) and cardiac remodeling/cytolysis (type III pro-collagene, troponine); 5) Cardiac autonomic function tests (R-R interval during Valsalva manoeuvre, deep-breathing, lying-to-standing). ;Timepoint(s) of evaluation of this end point: from baseline at 6 months | — |
Countries
Italy
Contacts
Public ContactU.O. Medicina Interna 1
U.O. Medicina Interna 1
Outcome results
None listed