Actively Recruiting
Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes
Led by University Medical Centre Ljubljana · Updated on 2026-04-30
90
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The main questions it aims to answer are: * Does early combination with two antidiabetic drugs improve blood glucose levels, determined by continuous glucose monitoring system? * Is early combination treatment as safe as treatment with a single antidiabetic drug? * Does early combination treatment reduces the need for rescue therapy? * Does early combination treatment reduces body weight and improves body composition? * Does early combination treatment improves blood lipid parameters, oxidative stress and inflammation? * Does early combination treatment improves metabolic parameters? * Does early combination treatment improves insulin resistance and insulin secretion? Researchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes. Participants will: * Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks. * Visit the clinic four times during the study duration for checkups and tests. * Carry a continuous glucose monitoring sensor for 14 days prior to study visits.
CONDITIONS
Official Title
Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes for up to 2 years before randomization
- Aged between 18 and 70 years, any sex, race, or ethnicity
- HbA1c level of 8.0% or less at randomization
- Taking metformin at a steady daily dose of at least 1500 mg
- Signed informed consent to participate in the study
You will not qualify if you...
- Previous treatment with SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors at any time
- Insulin treatment for more than 2 weeks in the past
- Body mass index (BMI) below 22 kg/m2 or above 40 kg/m2
- Chronic kidney disease stage 3-5 (eGFR below 60 ml/min or albuminuria above 34 g/mmol)
- Known cardiovascular diseases such as angina, heart attack, ischemic heart disease, heart failure, carotid atherosclerosis, or peripheral arterial disease
- Moderate or severe liver disease (Child-Pugh stage B or C)
- History of pancreatitis
- Advanced heart failure (NYHA class III-IV)
- Retinopathy or maculopathy or currently receiving active treatment for these
- Pregnancy, planning pregnancy, or breastfeeding
- Active cancer or cancer history within 5 years
- History of thyroid cancer or family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- Chronic inflammatory bowel disease
- History of bariatric or gastrointestinal surgery affecting drug or nutrient absorption
- Frequent or severe urinary tract infections
- Presence of a urinary catheter
- Recurrent genital fungal infections
- History of ketoacidosis
- Symptomatic low blood pressure or risk of low blood volume
- History of organ transplantation
- Allergy to any component of semaglutide or empagliflozin tablets
- Any medical or social condition limiting study participation
- Any condition that may affect treatment safety or effectiveness as judged by investigators
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Trial Site Locations
Total: 1 location
1
University Medical Centre Ljubljana, Diabetes Outpatient Clinic
Ljubljana, Slovenia, 1000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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