Background of the study

A group of glucose-lowering drugs, the sodium-glucose cotransporter-2 (SGLT2) inhibitors, have been shown to be very effective in the treatment of type 2 diabetes, reducing the progression of diabetic kidney disease. The study aims to investigate whether early treatment with the SGLT2 inhibitor dapagliflozin leads to improvement or prevention of kidney disease in individuals from one of the three high-risk groups of prediabetes with largely normal kidney function but already elevated urinary albumin excretion.

Eligible participants    

• Men and women between the ages of  35 and 75
• with a BMI ≥ 20 kg/m²
• and pre-diabetes (either HbA1c > 5,6 % or impaired glucose regulation)
• with previously (mostly unrecognized) early kidney damage

Key exclusion criteria

• Mental illnesses, taking psychotropic drugs
• People who are being treated with blood glucose-lowering medications
• Severe heart failure, cardiac pacemaker
• Malignant tumor diseases (cancer) in the last 5 years
• Anemia
• Pregnancy

Study procedure

The study duration is approximately 2 years, during which participants receive either the investigational drug or a placebo. In addition, they are instructed to perform a lifestyle intervention according to the guidelines. The medication is taken as a once-a-day tablet.
The participants receive detailed metabolic examinations.

Medical tests and examinations

• Medical physical examination
• Body measurements (weight, height, hip and waist circumference)
• Blood collections
• Metabolic tests
• Examination of the nervous system
• MRI (magnetic resonance imaging to determine abdominal and liver fat levels).

Reimbursement of expenses

All examinations are free of charge for you – the study center bears the costs. For financial compensation, please contact the respective study center.