| Outcome Measures: |
Primary: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on quality of life (QoL). KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status)., From baseline to week 16 | Secondary: Change in KCCQ clinical summary score, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status)., From baseline to week 4|Change in KCCQ overall summary score, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status)., From baseline to weeks 4 and 16|Proportion of participants with a ≥5, ≥10 and ≥15 point increase in KCCQ clinical and overall summary scores, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status). KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status)., From baseline to week 16|Change in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc), To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. Treatment satisfaction status score (no unit, ranges from 0 to 36, with higher scores reflecting greater treatment satisfaction). Treatment satisfaction change score (no unit, designed to overcome ceiling effects and to detect changes in treatment satisfaction on a scale from -18 to 18 with negative scores reflecting decreased treatment satisfaction, 0 reflecting no change and positive scores reflecting increased treatment satisfaction)., From baseline to week 16|Change in EQ-5D-5L questionnaire score, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. The instrument consists of two components: the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels (level 1 "no problems", level 2 "slight problems", level 3 "moderate problems", level 4 "severe problems", and level 5 "extreme problems"), from which a single EQ-5D index score can be calculated ranging from 0 to 1 where higher scores indicate higher health utility. The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health., From baseline to week 16|Change in distance covered during 6-minute walk test, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on walking distance, From baseline to week 16|Change in N-terminal pro b-type natriuretic peptide (NT-proBNP), To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on NT-proBNP, From baseline to week 16|Change in Haemoglobin A1c (HbA1c), To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on glycaemic control, From baseline to week 16|Proportion of participants with level 2 or level 3 hypoglycaemia, To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo, From baseline to weeks 16 and 20|Proportion of participants with diabetic ketoacidosis (DKA), To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo, From baseline to weeks 16 and 20|Proportion of participants requiring hospitalisation due to heart failure (HF), To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo, From baseline to weeks 16 and 20 | Other: Change in New York Heart Association (NYHA) class, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes, From baseline to weeks 16 and 20|Change in daily loop diuretic dose, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes, From baseline to week 16|Change in systolic and diastolic blood pressure., To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes, From baseline to week 16|Number of hospitalizations and deaths (first and total number) due to heart failure, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes, From baseline to weeks 16 and 20|Change in estimated glomerular filtration rate (eGFR), To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters, From baseline to week 16|Change in serum creatinine, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters, From baseline to week 16|Change in urine albumin to creatinine ratio, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters, From baseline to week 16|Change in total, basal and bolus insulin doses, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters, From baseline to week 16|Change in in body weight, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters, From baseline to week 16|Mean blood glucose level over preceding 14 days, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics, From baseline to week 16|Blood glucose percentage time in range (3.9-10.0 mmol/L) over preceding 14 days, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics, From baseline to week 16|Blood glucose percentage time below range (3.0-3.8 mmol/L and <3.0 mmol/L) over preceding 14 days, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics, From baseline to week 16|Blood glucose percentage time above range (10.1-13.9mmol/L and >13.9 mmol/L) over preceding 14 days, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics, From baseline to week 16|Glycaemic variability index, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics, From baseline to week 16|C-peptide level, To investigate if trial outcomes are associated with baseline c-peptide levels, At baseline|Proportion of participants with non-acidotic ketosis, To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on ketone levels, From baseline to week 16
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