Impact of empagliflozin on left ventricular functions
- Conditions
- type 2 diabetesMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-002225-10-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
•Male of female patients affected by type 2 diabetes mellitus (T2DM)
•Subjects aged >40 and <80 years
•HbA1c levels =53 and = 69 mmol/mol
•Assuming stable hypoglycemic therapy since three months with:
•Metformin
•Metformin + basal insulin
•Assuming stable cardio-active therapies since three months (anti-hypertensive drugs, diuretics, drugs for asthma, drugs for migraine)
•With preserved kidney function as defined by eGFR =45 ml.min-1.1.73m2
•With preserved left ventricular function as defined by (NYHA class 1-2, and EF=50%)
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 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38
•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;
•eGFR<45 ml/min/1.73 m2;
•Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method