Trial · NCT06435156
Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes
NCT06435156, Phase 2, Recruiting, University of Dundee
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes. Trials, record NCT06435156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06435156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes
- NCT number
- NCT06435156
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 320 participants, estimated
- Lead sponsor
- University of Dundee
- Conditions
- Type 1 Diabetes, Heart Failure
- Interventions
- Sotagliflozin, Placebo
- First posted
- 2024-05-30
- Last updated
- 2026-04-06
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06435156
GET https://conductscience.org/api/trials/v1/NCT06435156/registered?page=2