Trial · NCT06435156
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score | From baseline to week 16 | 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). |
| Secondary | Change in KCCQ clinical summary score | From baseline to week 4 | 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). |
| Secondary | Change in KCCQ overall summary score | From baseline to weeks 4 and 16 | 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). |
| Secondary | Proportion of participants with a ≥5, ≥10 and ≥15 point increase in KCCQ clinical and overall summary scores | From baseline to week 16 | 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). |
| Secondary | Change in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) | From baseline to week 16 | 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). |
| Secondary | Change in EQ-5D-5L questionnaire score | From baseline to week 16 | 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. |
| Secondary | Change in distance covered during 6-minute walk test | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on walking distance |
| Secondary | Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on NT-proBNP |
| Secondary | Change in Haemoglobin A1c (HbA1c) | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on glycaemic control |
| Secondary | Proportion of participants with level 2 or level 3 hypoglycaemia | From baseline to weeks 16 and 20 | To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo |
| Secondary | Proportion of participants with diabetic ketoacidosis (DKA) | From baseline to weeks 16 and 20 | To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo |
| Secondary | Proportion of participants requiring hospitalisation due to heart failure (HF) | From baseline to weeks 16 and 20 | To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo |
| Other | Change in New York Heart Association (NYHA) class | From baseline to weeks 16 and 20 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes |
| Other | Change in daily loop diuretic dose | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes |
| Other | Change in systolic and diastolic blood pressure. | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes |
| Other | Number of hospitalizations and deaths (first and total number) due to heart failure | From baseline to weeks 16 and 20 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes |
| Other | Change in estimated glomerular filtration rate (eGFR) | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters |
| Other | Change in serum creatinine | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters |
| Other | Change in urine albumin to creatinine ratio | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters |
| Other | Change in total, basal and bolus insulin doses | From baseline to week 16 | To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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