Combining two diabetes medications for better blood sugar control

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of early combination therapy using two antihyperglycemic medications, semaglutide and empagliflozin, on blood glucose control in adults diagnosed with type 2 diabetes for up to two years. Participants will be monitored for improvements in glycemic levels, body weight, blood lipids, and overall metabolic health, as well as the safety of this combination treatment compared to single-drug therapy. The study aims to address the potential benefits of initiating combination therapy early in the treatment process to enhance patient outcomes and reduce the need for additional rescue therapies.

Why it matters

Who can join: the full rules

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's running

• University Medical Centre Ljubljana, Diabetes Outpatient Clinic
  Ljubljana, Slovenia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.