Search / Trial NCT06613854

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

Launched by UNIVERSITY MEDICAL CENTRE LJUBLJANA · Sep 23, 2024

Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

E Sempa Early Combination Antihyperglycemic Treatment Metformin Semaglutide Empagliflozin Glycemic Control Metabolic Control Type 2 Diabetes Insulin Resistance Time In Range Cgm Continuous Glucose Monitoring Umc Ljubljana

Description

Type 2 diabetes (T2D) is a progressive chronic disease and represents a significant risk factor for morbidity and mortality due to cardiovascular disease. In addition to managing glycemia, the use of antihyperglycemic medications with further and independent cardiovascular benefits is recommended in managing individuals with T2D. These medications primarily include sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA). Traditionally, treatment of T2D followed a stepwise intensification by adding antihyperglycemic drugs if optimal glycemic...

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.

About University Medical Centre Ljubljana

University Medical Centre Ljubljana (UMCL) is a leading academic medical institution in Slovenia, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMCL integrates cutting-edge medical practices with comprehensive patient care, fostering an environment of collaboration among healthcare professionals, researchers, and patients. With a strong emphasis on ethical standards and scientific integrity, UMCL aims to contribute to the global body of medical knowledge while improving treatment outcomes in various therapeutic areas.

Locations

Ljubljana, , Slovenia

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0