Outcome Measures: |
Primary: Body weight change from baseline to week 16 of treatment, Change in body weight after 16 weeks of treatment, From week 0 to week 16 | Secondary: TIR [70-180] mg/dL., Time In Range \[70-180\] mg/dL change from baseline to week 16 of treatment as measured by CGM., From week 0 to week 16|%TIR [70-180] mg/dL., Percentage of Time In Range \[70-180\] mg/dL change from baseline to week 16 of treatment as measured by CGM., From week 0 to week 16|TIR [70-140] mg/dL., Time In Range \[70-140\] mg/dL change from baseline to week 16 of treatment as measured by CGM., From week 0 to week 16|%TIR [70-140] mg/dL., Percentage of Time In Range \[70-140\] mg/dL change from baseline to week 16 of treatment as measured by CGM., From week 0 to week 16|MeanG_24h, Average glucose over 24h change from baseline to week 16 of treatment, From week 0 to week 16|CVG_24h, Coefficient Of Variation of glucose over 24h change from baseline to week 16 of treatment., From week 0 to week 16|DistG_24h, Distance travelled over 24h change from baseline to week 16 of treatment, From week 0 to week 16|SDG_24h, Standard Deviation of all glucose values over 24h change from baseline to week 16 of treatment, From week 0 to week 16|HbA1c, HbA1c change from baseline to week 16 of treatment, From week 0 to week 16|Total Insulin doses, Change from baseline of total insulin doses, From week 0 to week 16|Prandial Insulin doses, Change from baseline of prandial (per meal), insulin doses, From week 0 to week 16|Basal Insulin doses, Change from baseline of basal insulin doses, From week 0 to week 16|Number of Adverse Events, Number of Adverse Events observed during the treatment period, From week 0 to week 16|Duration of Adverse Events, Duration of Adverse Events observed during the treatment period, From week 0 to week 16|Hypoglycaemic episodes, Number of Hypoglycemic episodes during the 16 weeks treatment period, From week 0 to week 16
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