Combining two diabetes medications for better blood sugar control

Effect of Early Combination Antihyperglycemic Treatment With Metformin and Oral Semaglutide vs. Metformin and Empagliflozin on Glycemic and Metabolic Control in Individuals With Short Duration Type 2 Diabetes

This study is testing if using two diabetes medications together can help adults with type 2 diabetes better control their blood sugar and improve their overall health.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University Medical Centre Ljubljana (other)
• Locations: 1 site (Ljubljana)
• Trial ID: NCT06613854 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a recent diagnosis of type 2 diabetes and a specific HbA1c level.

Not a fit: Patients with a history of certain cardiovascular diseases or those who have previously used specific diabetes medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved blood sugar control and better overall health outcomes for patients with type 2 diabetes.

How similar studies have performed: Previous studies on early combination therapy for type 2 diabetes have shown promising results, indicating potential benefits in glycemic control.

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.

Where this trial is running

Ljubljana

• University Medical Centre Ljubljana, Diabetes Outpatient Clinic — Ljubljana, Slovenia (RECRUITING)

Conditions: Type 2 Diabetes Mellitus, E-SEMPA, Early Combination Antihyperglycemic Treatment, Metformin, Semaglutide, Empagliflozin, Glycemic Control, Metabolic Control