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.
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;
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);
Parallel
Oral semaglutide
DrugSemaglutide Oral Tablets will be introduced to the Oral Semaglutide Arm as per protocol for regular therapy introduction.
Empagliflozin 10 mg
DrugEmpagliflozin Oral Tablets will be introduced to the Empagliflozin Arm as per protocol for regular therapy introduction.
Time in Range (TIR)
Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.9-10.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes).
Absolute Change in Time in Range (TIR)
Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes).
Absolute Change in Glycated hemoglobin (HbA1c)
Assessment by biochemical methods (in %)
Time above Range (TAR)
Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is above 10.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes).
Time below Range (TBR)
Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is below 3.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes).
Change in Body Weight
Measured in kg.
Proportion of participants with a reduction of Body Weight above or equal to 5%
Measured in %.
Proportion of participants with a reduction of Body Weight above or equal to 10%
Measured in %.
Change in Waist Circumference
Measured in cm.
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