LIFETIME

Background of the study

More than 50% of people with type 2 diabetes mellitus develop a wide variety of diabetes-related complications. Current guidelines stipulate that patients should only be treated with medication once the disease has manifested itself. However, studies show that some people have already developed complications at this stage. It therefore seems sensible to treat patients at the prediabetic stage. Prediabetes refers to a condition of slightly elevated blood sugar levels, which can often be observed years before the disease manifests itself.  A group of glucose-lowering drugs, sodium-glucose cotransporter 2 (SGLT2) inhibitors, have proven to be very effective in the treatment of type 2 diabetes. It is not yet clear whether they also cause a relevant reduction in blood sugar levels in the prediabetic stage and can thus prevent the occurrence of complications in the long term. 

Eligible participants

• Men and women between the ages of  35 and 75
• with a BMI ≥ 20 kg/m²

• with prediabetes (defined as impaired fasting glucose (≥100 mg/dL and <126 mg/dL) and/or elevated 2-hour glucose levels in the oral glucose tolerance test (OGTT) (≥140 mg/dL and <200 mg/dL); elevated HbA1c with normal glucose regulation is not sufficient)

   

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 lasts approximately six months, during which participants receive either the test drug or a placebo. In addition, they are instructed to implement lifestyle changes in accordance with the guidelines. The medication is taken once daily in tablet form. Follow-up examinations are scheduled after seven and 12 months. Participants undergo detailed metabolic testing.

Medical tests and examinations

• Medical physical examination
• Body measurements (weight, height, hip and waist circumference)
• Blood collections
• Metabolic tests
• Examination of the nervous system
• Whole-body 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.