| Outcome Measures: |
Primary: Change TIR, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 CGM percent time spent between 3.9 and 10 mmol/L (TIR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks. | Secondary: Change TIR daytime, Mean difference (change) from baseline and after 12 weeks of treatment in the daytime (7-23h) CGM percent time spent between 3.9 and 10 mmol/L (TIR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TTR, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 CGM percent time spent between 3.9 and 7.8 mmol/L (TTR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change mean glucose, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 in mean glucose comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change CV, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 in the coefficient of variation (CV) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change Glucose SD, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 in the standard deviation of glucose comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change LBGI, Mean difference (change) from baseline and after 12 weeks of treatment in low blood glucose index (LBGI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change HBGI, Mean difference (change) from baseline and after 12 weeks of treatment in high blood glucose index (HBGI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TDI, Mean difference (change) from baseline and after 12 weeks of treatment in high total daily insulin (TDI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TDBa, Mean difference (change) from baseline and after 12 weeks of treatment in total daily basal (TDBa) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TDBo, Mean difference (change) from baseline and after 12 weeks of treatment in total daily bolus (TDBo) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change Glycated Hemoglobin (HbA1C), Mean difference (change) from baseline and after 12 weeks of treatment in glycated hemoglobin (HbA1C) comparing tirzepatide+SoC (intervention) vs. SoC (control)., At the end of the observation period (week 16)|Change BW, Mean difference (change) from baseline and after 12 weeks of treatment in body weight (BW) comparing tirzepatide+SoC (intervention) vs. SoC (control)., At the end of the observation period (week 16)|Change DTSQ, Mean difference (change) from baseline and after 12 weeks of treatment in Patient-reported outcomes: DTSQc (baseline)/DTSQc (last visit-end of treatment) comparing tirzepatide+SoC (intervention) vs. SoC (control)., At the end of the observation period (week 16)|Change TIR 4w, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 CGM percent time spent between 3.9 and 10 mmol/L (TIR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TIR daytime 4w, Mean difference (change) from baseline and after 4 weeks of treatment in the daytime (7-23h) CGM percent time spent between 3.9 and 10 mmol/L (TIR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TTR 4w, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 CGM percent time spent between 3.9 and 7.8 mmol/L (TTR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TAR 4w, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 CGM percent time spent higher than 10 mmol/L (TAR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TAR, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 CGM percent time higher than 10 mmol/L (TAR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TAR Level 2, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 CGM percent time higher than 13.9 mmol/L (TAR level 2) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TAR Level 2 4w, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 CGM percent time higher than 13.9 mmol/L (TAR level 2) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TBR, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 CGM percent time lower than 3.9 mmol/L (TBR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TBR 4w, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 CGM percent time lower than 3.9 mmol/L (TBR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TBR Level 2, Mean difference (change) from baseline and after 12 weeks of treatment in 24/7 CGM percent time lower than 3.0 mmol/L (TBR level 2) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TBR Level 2 w4, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 CGM percent time lower than 3.0 mmol/L (TBR level 2) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change mean glucose 4w, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 in mean glucose comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change CV 4w, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 in the coefficient of variation (CV) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change Glucose SD 4w, Mean difference (change) from baseline and after 4 weeks of treatment in 24/7 in the standard deviation of glucose comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change LBGI 4w, Mean difference (change) from baseline and after 4 weeks of treatment in low blood glucose index (LBGI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change HBGI 4w, Mean difference (change) from baseline and after 4 weeks of treatment in high blood glucose index (HBGI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TDI 4w, Mean difference (change) from baseline and after 4 weeks of treatment in high total daily insulin (TDI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TDBa 4w, Mean difference (change) from baseline and after 4 weeks of treatment in total daily basal (TDBa) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TDBo 4w, Mean difference (change) from baseline and after 4 weeks of treatment in total daily bolus (TDBo) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8|Change TIR 8w, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 CGM percent time spent between 3.9 and 10 mmol/L (TIR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TIR daytime 8w, Mean difference (change) from baseline and after 8 weeks of treatment in the daytime (7-23h) CGM percent time spent between 3.9 and 10 mmol/L (TIR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TTR 8w, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 CGM percent time spent between 3.9 and 7.8 mmol/L (TTR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change mean glucose 8w, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 in mean glucose comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change CV 8w, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 in the coefficient of variation (CV) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change Glucose SD 8w, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 in the standard deviation of glucose comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change LBGI 8w, Mean difference (change) from baseline and after 8 weeks of treatment in low blood glucose index (LBGI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change HBGI 8w, Mean difference (change) from baseline and after 8 weeks of treatment in high blood glucose index (HBGI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TDI 8w, Mean difference (change) from baseline and after 8 weeks of treatment in high total daily insulin (TDI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TDBa 8w, Mean difference (change) from baseline and after 8 weeks of treatment in total daily basal (TDBa) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TDBo 8w, Mean difference (change) from baseline and after 8 weeks of treatment in total daily bolus (TDBo) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TAR 8w, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 CGM percent time higher than 10 mmol/L (TAR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TAR Level 2 w8, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 CGM percent time higher than 13.9 mmol/L (TAR level 2) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TBR 8w, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 CGM percent time lower than 3.9 mmol/L (TBR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12|Change TBR Level 2 w8, Mean difference (change) from baseline and after 8 weeks of treatment in 24/7 CGM percent time lower than 3.0 mmol/L (TBR level 2) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 12 | Other: Change hip circumference, Mean difference (change) from baseline and after 12 weeks of treatment in hip circumference comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change cholesterol non-HDL, Mean difference (change) from baseline and after 12 weeks of treatment in cholesterol non-HDL comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change waist-to-hip ratio, Mean difference (change) from baseline and after 12 weeks of treatment in waist-to-hip ratio comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change % fat mass, Mean difference (change) from baseline and after 12 weeks of treatment in % of fat mass comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change fat mass index, Mean difference (change) from baseline and after 12 weeks of treatment in fat mass index (FMI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change visceral adipose tissue, Mean difference (change) from baseline and after 12 weeks of treatment in visceral adipose tissue comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change Lean Mass Index, Mean difference (change) from baseline and after 12 weeks of treatment in lean mass index (LMI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change Appendicular Lean Mass Index, Mean difference (change) from baseline and after 12 weeks of treatment in appendicular lean mass index (ALMI) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change LDL, Mean difference (change) from baseline and after 12 weeks of treatment in low-density cholesterol lipoprotein (LDL) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change HDL, Mean difference (change) from baseline and after 12 weeks of treatment in high-density cholesterol lipoprotein (HDL) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change Triglycerides, Mean difference (change) from baseline and after 12 weeks of treatment in triglycerides comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change TG-glucose index, Mean difference (change) from baseline and after 12 weeks of treatment in TG-glucose index in fasting comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change blood pressure, Mean difference (change) from baseline and after 12 weeks of treatment in systolic and diastolic blood pressure comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change Albumin to Creatinine, Mean difference (change) from baseline and after 12 weeks of treatment in albumin to creatinine ratio (uACR) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change CAP-value, Mean difference (change) from baseline and after 12 weeks of treatment in hepatic steatosis and fibrosis (FibroScan) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change MASLD, Mean difference (change) from baseline and after 12 weeks of treatment in MASLD biomarkers comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change HIS, Mean difference (change) from baseline and after 12 weeks of treatment in hepatic steatosis index (HIS) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change FIB-4, Mean difference (change) from baseline and after 12 weeks of treatment in fibrosis score (FIB-4) comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to the end of the observation period (week 16) for a total of 12 weeks.|Change Waist Circumference, Mean difference (change) from baseline and after 12 weeks of treatment in waist circumference comparing tirzepatide+SoC (intervention) vs. SoC (control)., From up-titration (week 4) to week 8
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