Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes
Recruiting · NCT06613854 · Interventional (participants receive a specific treatment) · Lead sponsor: University Medical Centre Ljubljana
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 early combination treatment improves blood lipid parameters, oxidative stress and inflammation? * Does early combination treatment improves metabolic parameters? * Does early combination treatment improves insulin resistance and insulin secretion? Researchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes. Participants will: * Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks. * Visit the clinic four times during the study duration for checkups and tests. * Carry a continuous glucose monitoring sensor for 14 days prior to study visits.
Who can take part
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.
Where it is running
1 location listed.
- University Medical Centre Ljubljana, Diabetes Outpatient Clinic - Ljubljana, Slovenia