| Outcome Measures: |
Primary: 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)., Period of 14 days prior to last study visit (week 26) | Secondary: Absolute Change in Time in Range (TIR), Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes)., Baseline (week 0) and last study visit (week 26)|Absolute Change in Glycated hemoglobin (HbA1c), Assessment by biochemical methods (in %), Baseline (week 0) and last study visit (week 26)|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)., Last study visit (week 26)|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)., Last study visit (week 26)|Time above Range (TAR) - Level 1 Hyperglycemia, Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 10.1-13.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes)., Last study visit (week 26)|Time above Range (TAR) - Level 2 Hyperglycemia, Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is above 13.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes)., Last study visit (week 26)|Time below Range (TBR) - Level 1 Hypoglycemia, Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.0-3.8 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes)., Last study visit (week 26)|Time below Range (TBR) - Level 2 Hypoglycemia, Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is below 3.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes)., Last study visit (week 26)|Time in Tight Range (TITR), Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.9-7.8 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes)., Last study visit (week 26)|Coefficient of variation (CV), A measure of dynamic glucose variability. Calculated as a ratio of glucose concentration standard deviation and mean glucose concentration, expressed as a percentage. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %)., Last study visit (week 26)|Mean Time in Range (TIR), Mean Time in Range (TIR) at study visit at week 13 and week 26. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes)., Study visit at week 13 and week 26|Mean glucose concentration, Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in mmol/L)., Last study visit (week 26)|Proportion of participants with Coefficient of variation (CV) below or equal to 36%, Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %)., Last study visit (week 26)|Standard deviation of mean glucose concentration, Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in mmol/L)., Last study visit (week 26)|Proportion of participants with Time in Range (TIR) above 70%, Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %)., Last study visit (week 26)|Proportion of participants with Time in Range (TIR) above 90%, Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %)., Last study visit (week 26)|Proportion of participants with Glycated hemoglobin (HbA1c) below 6.5%, Assessment by biochemical methods (in %), Last study visit (week 26)|Proportion of participants with Glycated hemoglobin (HbA1c) below 5.7%, Assessment by biochemical methods (in %)., Last study visit (week 26)|Proportion of participants requiring rescue therapy with gliclazide, Measured in %., Baseline (week 0) to last study visit (week 26)|Proportion of participants with severe hypoglycemia, Severe hypoglycemia is an epizode of hypoglycemia requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Measured in %., Baseline (week 0) to last study visit (week 26)|Proportion of participants with severe adverse events, Severe adverse event is defined as symptoms that significantly affects daily activities. Assessment by patients themselves. Measured in %., Baseline (week 0) to last study visit (week 26)|Proportion of patients withdrawing from the trial due to adverse events of the interventional drugs, Assessment by patients themselves. Measured in %., Baseline (week 0) to last study visit (week 26) | Other: Change in Body Weight, Measured in kg., Baseline (week 0) and last study visit (week 26)|Proportion of participants with a reduction of Body Weight above or equal to 5%, Measured in %., Baseline (week 0) and last study visit (week 26)|Proportion of participants with a reduction of Body Weight above or equal to 10%, Measured in %., Baseline (week 0) and last study visit (week 26)|Change in Waist Circumference, Measured in cm., Baseline (week 0) and last study visit (week 26)|Change in Visceral Adipose Tissue Mass, Assessment by Dual x-ray absorptiometry. Measured in g., Baseline (week 0) and last study visit (week 26)|Change in the Proportion of the Total Body Fat Mass, Assessment by Dual x-ray absorptiometry. Measured in %., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Total Cholesterol (TC), Assessment by biochemical methods (in mmol/L)., Baseline (week 0) and last study visit (week 26)|Change in Concentration of High Density Lipoprotein Cholesterol (HDL-C), Assessment by biochemical methods (in mmol/L)., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Low Density Lipoprotein Cholesterol (LDL-C), Assessment by biochemical methods (in mmol/L)., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Triglycerides (TG), Assessment by biochemical methods (in mmol/L)., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Apolipoprotein A1 (ApoA1), Assessment by biochemical methods (in mmol/L)., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Apolipoprotein B (ApoB), Assessment by biochemical methods (in mmol/L)., Baseline (week 0) and last study visit (week 26)|Change in Total Antioxidant Status, Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Glutathione Peroxidase Activity in Erythrocytes, Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Superoxide Dismutase Activity in Erythrocytes, Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Uric Acid, Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Advanced Oxidation Protein Products (AOPP), Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Advanced Glycosylation End Products (AGE), Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Concentration of 8-Isoprostane, Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Concentration of high-sensitivity C-reactive protein (hs-CRP), Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Interleukin-6 (IL-6), Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Beta-hydroxybutyrate, Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Free Fatty Acids, Assessment by biochemical methods., Baseline (week 0) and last study visit (week 26)|Change of Insulin Resistance - Matsuda Index, Insulin Resistance will be estimated from Matsuda Index from modified Oral Glucose Tolerance Test (mOGTT). Lower values of Matsuda Index mean a higher level of insulin resistance., Baseline (week 0) and last study visit (week 26)|Change of Insulin Resistance - HOMA-IR, Insulin Resistance will be estimated from Homeostasis Model Assessment for Insulin Resistance (HOMA-IR). Higher values of HOMA-IR mean higher insulin resistance., Baseline (week 0) and last study visit (week 26)|Change of Insulin Sensitivity - HOMA2-%S, Homeostatic model assessment (HOMA) will be used to calculate insulin sensitivity. It will be reported as HOMA2-%S (where 100% means normal insulin sensitivity). HOMA2-%S is reciprocal of Homeostasis Model Assessment for Insulin Resistance - HOMA-IR. Calculated using HOMA2 Calculator v2.2.4, Oxford Centre for Diabetes, Endocrinology and Metabolism; Oxford University, United Kingdom., Baseline (week 0) and last study visit (week 26)|Change of Pancreatic Beta Cell Function - HOMA2-%B, Pancreatic Beta Cell Function will be estimated from Homeostasis Model Assessment 2 of B-cell Function (HOMA2-%B), where 100% means normal Beta cell function. Calculated with HOMA2 Calculator v2.2.4, Oxford Centre for Diabetes, Endocrinology and Metabolism; Oxford University, United Kingdom., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Alanine, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Leucine, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Isoleucine, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Valine, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Phenylalanine, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Methionine, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Lysine, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Glutamate, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Acylcarnitine C5, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Acylcarnitine C8:1, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Acylcarnitine C5-OH, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Acylcarnitine C4-OH, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)|Change in Concentration of Acylcarnitine C4-DC, Assessment by biochemical methods, including tandem mass spectrometry., Baseline (week 0) and last study visit (week 26)
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