Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics

Exclusion Criteria

• •Subjects presenting with any of the following criteria at visit 0 (screening) will not be included in the trial:
• •Pretreatment with empagliflozin or other SGLT2 inhibitor within the last 3 months
• •Pretreatment with known inducers of UGT enzymes
• •Uncontrolled hyperglycemia with a glucose level \> 240 mg/dl (\>13.3 mmol/L) after an overnight fast
• •Impaired renal function, defined as eGFR \<45 ml/min/1.73 m² of body-surface-area
• •End-stage renal failure or dialysis
• •Severe hepatic dysfunction, defined by serum levels of either SGPT, SGOT, or alkaline phosphatase above 3 x upper limit of normal (ULN)
• •Acute urinary tract infection (UTI)
• •Known acute genital infection (GI)
• •Symptomatic hypotension
• •Hematocrit above the upper limit of the reference range
• •Hypoglycemic tendencies
• •Severe PAD (Fontaine classification Stage IIb - IV)
• •Medical history of cancer and/or treatment for cancer within the last 5 years, subjects basalioma can be included in the study
• •Medical history of pancreatitis or surgery on pancreas
• •Known ketoacidosis (in the past)
• •Acute febrile disease
• •NYHA classification III - IV
• •Pregnant and/or nursing women at visit 1 (baseline)
• •Acute coronary syndrome, stroke or TIA within the last 2 months
• •Planned cardiac surgery or angioplasty within 3 months
• •Gastrointestinal surgeries that induce chronic malabsorption
• •Blood dyscrasia or any disorders causing hemolysis or unstable Red Blood Cells (e.g. malaria, babesiosis, hemolytic anemia)
• •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
• •Alcohol or drug abuse within the last 3 months that would interfere with trial participation
• •Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial (at visit 0 (screening) or at visit 1 (baseline))
• •Medical condition that does not allow enrollment in the trial at visit 1 (baseline)
• •Current treatment with systemic steroids or change in dosage of thyroid hormones within the last 6 weeks or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
• •Hereditary glucose intolerance, galactose intolerance, Lapp-lactase deficiency or glucose-galactose-malabsorption
• •Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial (involving an investigational drug and/or follow-up)