| Outcome Measures: |
Primary: Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L), %-point, From week 0 (baseline) to week 26 (end of treatment) | Secondary: Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of hemoglobin A1c (mmol/mol), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Time spent in target blood glucose range (3.9 - 10 mmol/L) evaluated by a continous glucose monitor (CGM), (% of 24 hours), From week 0 (baseline) to week 26 (end of treatment)|Time spent in hyperglycemia level 1 (10-13.9 mmol/L) evaluated by a continous glucose monitor (CGM), (% of 24 hours), From week 0 (baseline) to week 26 (end of treatment)|Time spent in hyperglycemia level 2 (> 13.9 mmol/L) evaluated by a continous glucose monitor (CGM), (% of 24 hours), From week 0 (baseline) to week 26 (end of treatment)|Time spent in hypoglycemia level 1 (3.0-3.8 mmol/L) evaluated by a continous glucose monitor (CGM), (% of 24 hours), From week 0 (baseline) to week 26 (end of treatment)|Time spent in hypoglycemia level 2 (< 3.0 mmol/L)evaluated by a continous glucose monitor (CGM), (% of 24 hours), From week 0 (baseline) to week 26 (end of treatment)|Insulin dosage, Number of units/day (both long- and short-acting insulin analogues), From week 0 (baseline) to week 30 (safety follow-up)|Change in body weight (kg), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in waist:hip ratio, %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of low-density lipoprotein cholesterol (LDL) (mmol/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of interleukin (IL)-6 (pg/mL), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of tumor necrosis factor alpha (pg/mL), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Safety-related events, Serious adverse events (SAE), events of severe hypoglycemia, events of diabetic ketoacidosis, From week 0 (baseline) to week 30 (safety follow-up) | Other: Change in fasting serum/plasma concentrations of fibrinogen (µmol/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of serum amyloid A (mg/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of haptoglobin (g/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of interleukin (IL)-1β (pg/mL), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of interleukin (IL)-2 (pg/mL), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of intercellular adhesion molecule 1 (ICAM-1) (pg/mL), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of vascular cell adhesion molecule 1 (VCAM-1) (pg/mL), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of total leukocyte count, including neutrophil, lymphocyte, basophil and eosinophil counts (10^9/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in neutrophil:lymphocyte ratio, %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of very low-density lipoprotein (VLDL) cholesterol (mmol/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of high-density lipoprotein (HDL) cholesterol (mmol/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of total cholesterol (mmol/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of triglycerides (mmol/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in fasting serum/plasma concentrations of lipoprotein (a) (mg/L), %-point, From week 0 (baseline) to week 30 (safety follow-up)|Change in thrombocyte function measured by thromboelastography, %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in fasting serum/plasma concentrations of N-terminal pro-brain natriuretic peptide (pro-BNP) (pmol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in consultation blood pressure (mmHg), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in heart rate (beats/minute), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of estimated glomerular filtration rate (eGFR) (mL/min/1.73 m2), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of albumin (g/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in urine albumin-to-creatinine ratio (mg/g), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change left ventricular (LV) mass index evaluated by cardiovascular ultrasonography (g/m^2), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change left ventricular (LV) septal wall thickness evaluated by cardiovascular ultrasonography (mm), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change left ventricular (LV) posterior wall thickness evaluated by cardiovascular ultrasonography (mm), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change left ventricular (LV) ejection fraction (LVEF) evaluated by cardiovascular ultrasonography (%), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change ratio of peak velocity blood flow from left ventricular relaxation in early diastole (E) to peak velocity flow in late diastole caused by atrial contraction (A) (E/A ratio) evaluated by cardiovascular ultrasonography, %-point, From week 0 (baseline) to week 26 (end of treatment)|Change early diastolic mitral inflow velocity (e') evaluated by cardiovascular ultrasonography (m/sec), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change ratio of early diastolic mitral inflow velocity (e') to early diastolic mitral annulus velocity (E) (E/e' ratio) evaluated by cardiovascular ultrasonography, %-point, From week 0 (baseline) to week 26 (end of treatment)|Change ratio of early mitral inflow velocity (E) to global diastolic strain rate (e' sr) (E/e'sr ratio) evaluated by cardiovascular ultrasonography, %-point, From week 0 (baseline) to week 26 (end of treatment)|Change left atrial volume (LAVi) evaluated by cardiovascular ultrasonography (mL), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change global longitudinal strain (GLS) evaluated by cardiovascular ultrasonography (%), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change aortic distensibility evaluated by cardiovascular ultrasonography (mmHg^-1), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change aortic strain evaluated by cardiovascular ultrasonography (%), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in mean glucose evaluated by a continous glucose monitor (mmol/L), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in standard deviation evaluated by a continous glucose monitor (mmol/L), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in coefficient of variance evaluated by a continous glucose monitor (> 0.36 defined as glycemic variability), %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in glycemic variability (continuous overall net glycemic action (CONGA)) evaluated by a continous glucose monitor, %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in mean amplitude of glycemic excursion evaluated by a continous glucose monitor, %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in diabetes treatment satisfactory questionnaire, status version (DTSQs) (From 0 (min) to 6 (max), higher scores indicate a better outcome ), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in diabetes treatment satisfactory questionnaire, change version (DTSQc) (From -3 (min) to 3 (max), higher scores indicate a better outcome), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in audit of diabetes-dependent quality of life questionnaire (ADDQoL) (From -9 (min) to 9 (max), higher scores indicate a better outcome ), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of ketones (mmol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Adverse events, As reported by participants, From week 0 (baseline) to week 30 (end of treatment)|Change in liver fat content as per the CAP score (dB/m) measured by FibroScan®, %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in liver fibrosis score (kPa) measured by FibroScan®, %-point, From week 0 (baseline) to week 26 (end of treatment)|Change in fibrosis-4 (FIB-4) score (numerical scale, higher scores indicate a higher risk of fibrosis), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fatty liver index (FLI) score (numerical scale, higher scores indicate a higher risk of fibrosis), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of hemoglobin (mmol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of thrombocytes (10^9/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of glucose (mmol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of potassium (mmol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of sodium (mmol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of creatinine (umol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of alanine aminotransferase (U/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of aspartate aminotransferase (U/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of bilirubin (umol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of amylase (units/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of creatine kinase (U/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of C-peptide (pmol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of glucagon (pmol/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of C-terminal telopeptide (ng/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in fasting serum/plasma concentrations of procollagen type 1 N-terminal propeptide (ng/L), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in body composition by bioimpedance analysis, %-point (fat free mass, total fat mass, muscle mass, bone mass), From week 0 (baseline) to week 26 (end of treatment)|Change in body mass index (kg/m^2), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in waist circumference (cm), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in hip circumference (cm), %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in waist:hip ratio, %-point, From week 0 (baseline) to week 30 (end of treatment)|Change in interleukin messenger ribonucleic acid (mRNA) expression measured by quantitative polymerase chain reaction, %-point, From week 0 (baseline) to week 26 (end of treatment)
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