Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes

Launched by UNIVERSITY MEDICAL CENTRE LJUBLJANA · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether using two diabetes medications together early on can help people with type 2 diabetes control their blood sugar better than using just one medication. The researchers want to find out if this combination treatment not only improves blood glucose levels but also affects body weight, fat distribution, cholesterol levels, and inflammation in a positive way. They aim to see if combining these medications is safe and if it can reduce the need for additional treatments in the future.

To participate in this trial, individuals need to be between 18 and 70 years old, have been diagnosed with type 2 diabetes for up to 2 years, and currently be taking a stable dose of metformin. Participants will take either the combination of two diabetes drugs or just metformin for 26 weeks and will have regular check-ups to monitor their health. Before starting the trial, they will wear a glucose monitor for 14 days to track their blood sugar levels. This study is currently looking for volunteers, and it’s important for interested individuals to review the full eligibility criteria with their healthcare provider to ensure it’s a good fit for them.

Gender

ALL

Eligibility criteria

• 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.