💬In plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to learn if early combination with two antidiabetic drugs further improves blood glucose control compared to a single drug regimen in adults with short duration of type 2 diabetes. It will also learn about the effect of the combination treatment on body weight, body composition, blood lipids, oxidative stress, inflammation, metabolic control, insulin resistance and insulin secretion from pancreas, together with its safety profile. The main questions it aims to answer are:
* Does early combination with two antidiabetic drugs improve blood glucose levels, determined by continuous glucose monitoring system?
* Is early combination treatment as safe as treatment with a single antidiabetic drug?
* Does early combination treatment reduces the need for rescue therapy?
* Does early combination treatment reduces body weight and improves body composition?
* Does
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Diagnosed with type 2 diabetes for up to 2 years (prior to randomization);
* Aged between 18 and 70 years, both sexes, of any race or ethnicity;
* HbA1c ≤8.0% at randomization;
* Baseline treatment with metformin at a steady daily dose of ≥1500 mg;
* Signed informed consent to participate in the study.
Exclusion Criteria:
* Treatment at any time in the past with SGLT2i, GLP-1RA, or DPP-4 inhibitors;
* Insulin treatment for longer than 2 weeks in the past;
* Body Mass Index below 22 kg/m2 or BMI above 40 kg/m2;
* Chronic kidney disease stages 3-5 (eGFR below 60 ml/min or the presence of albuminuria (urine albumin-to-creatinine ratio above 34 g/mmol);
* Known cardiovascular disease (angina pectoris, history of myocardial infarction, ischemic heart disease, heart failure, known carotid atherosclerosis, objectively proven peripheral arterial disease, or other known atherosclerotic disease at other locations);
* Moderate or severe liver disease (Child-Pugh stage B or C);
* Personal history of pancreatitis;
* Advanced heart failure (NYHA III-IV);
* Retinopathy or maculopathy or their active treatment;
* Pregnancy, expected pregnancy, or breastfeeding;
* Presence of active malignancy or personal history of malignancy within 5 years of study enrollment;
* Personal history of thyroid cancer; personal or family history of multiple endocrine neoplasia type 2 or family history of medullary thyroid carcinoma;
* Chronic inflammatory bowel disease;
* History of bariatric surgery or other gastrointestinal surgery that could affect drug or nutrient absorption;
* Frequent or severe urinary tract infections;
* Presence of a urinary catheter;
* Troublesome and recurrent genital fungal infections;
* Personal history of ketoacidosis;
* Symptomatic hypotension or predisposition to hypovolemia;
* History of organ transplantation;
* Allergy to any component in the semaglutide or empagliflozin oral tablet;
* Any medical or social circumstance that may limit participation in the study (e.g., inability to attend regular study visits);
* Any other condition that, in the opinion of the principal and responsible investigators, may affect the safety or efficacy of the treatment.
💊
What it tests
- Oral semaglutide
- Empagliflozin 10 mg
University Medical Centre Ljubljana, Diabetes Outpatient Clinic
Ljubljana, Slovenia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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