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New treatment option for Type 2 Diabetes Mellitus (T2DM)
Official title Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes
ClinicalTrials.gov ID: NCT06613854
What this study is testing
What is Oral semaglutide?
Oral semaglutide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for type 2 diabetes mellitus (t2dm).
Also referred to as Rybelsus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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...
- Moderate or severe liver disease (Child-Pugh stage B or C);
See the full eligibility 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.
- 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...
- 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 how well it works of the treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.