Empagliflozin and its effect on heart failure in type 2 diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 270

Inclusion Criteria

1.Male or female patients aged > 18 years and = 85 years old
2.A diagnosis of type 2 diabetes mellitus with duration = 3 months
3.HbA1c = 6.5 and = 10.0% at screening
4.NYHA class I-IV
5.Treatment with one or two oral anti-diabetic medications (metformin, DPP-IV inhibitors, GLP-1 receptor agonists, acarbose, sulfonylureas) or treatment with any insulin alone or in combination with one or two oral anti-diabetic medications
6.Estimated glomerular filtration rate (eGFR) = 45 ml/min/1.73cm²
7.Written informed consent obtained according to international guidelines and local laws
8.Ability to understand the nature of the trial and the trial related procedures and to comply with them

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1.Type 1 diabetes mellitus
2.Treatment with empagliflozin or other SGLT-2 inhibitors for more than 7 consecutive days within 2 months prior to registration
3.Treatment with pioglitazone or other glitazones at registration
4.Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes within 30 days prior to registration
5.Current acute decompensated HF requiring augmented therapy with diuretics, vasodilators and/or inotropic drugs within 30 days prior to registration
6.History of stroke or cardiac surgery, or percutaneous coronary intervention within 60 days prior to registration
7.Transcatheter/transapical aortic valve Implantation (TAVI) or MitraClip procedure within six months preceding registration
8.Implantation of cardiac resynchronisation therapy (CRT) device or cardiac contractility modulation (CCM) device within six months preceding registration (for implantable cardioverter-defibrillator (ICD) and pacemaker a necessary lapse of time prior registration will be defined by the investigator)
9.Uncontrolled hypertension (systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg measured in resting seated position for 10 minutes)
10.Symptomatic hypotension, or an SBP < 85 mmHg
11.Blood haemoglobin < 10 g/dl
12.Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
13.Severe hepatic impairment
14.Known latent autoimmune diabetes in adults (LADA) or chronic pancreatitis

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

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