Trial · NCT03521934

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

NCT03521934, Phase 3, Terminated, Lexicon Pharmaceuticals; results first posted 2022-10-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial). Trials, record NCT03521934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03521934

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
NCT number: NCT03521934
Status: Terminated
Phases: Phase 3
Enrollment: 1,222 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Heart Failure, Type 2 Diabetes Mellitus
Interventions: Sotagliflozin, Placebo
First posted: 2018-05-11
Last updated: 2022-10-28
Other registries' IDs: eudract:2017-003510-16
Results first posted: 2022-10-28
Limitations and caveats: Limitations of the trial such as small numbers of participants analyzed or technical problems leading to unreliable data.~The study was terminated prematurely due to business decision.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)	Up to 21.9 months	Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Secondary	Total Number of Occurrences of HHF and Urgent HF Visits	Up to 21.9 months	Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Secondary	Total Number of Deaths From Cardiovascular Causes	Up to 21.9 months	Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Secondary	Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke	Up to 21.9 months	Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Secondary	Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized	Up to 21.9 months	Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Secondary	Total Number of Deaths From Any Cause	Up to 21.9 months	Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Secondary	Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4	Baseline to Month 4	KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis.
Secondary	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)	Baseline up to 21.9 months	eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2). A mixed model for repeated measures (MMRM) was used for analysis.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)	Up to 21.9 months	ITT population includes all randomized participants.	events per 100-person years	NUMBER
SECONDARY	Total Number of Occurrences of HHF and Urgent HF Visits	Up to 21.9 months	ITT population includes all randomized participants.	events per 100-person years	NUMBER
SECONDARY	Total Number of Deaths From Cardiovascular Causes	Up to 21.9 months	ITT population includes all randomized participants.	events per 100-person years	NUMBER
SECONDARY	Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke	Up to 21.9 months	ITT population includes all randomized participants.	events per 100-person years	NUMBER
SECONDARY	Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized	Up to 21.9 months	ITT population includes all randomized participants.	events per 100-person years	NUMBER
SECONDARY	Total Number of Deaths From Any Cause	Up to 21.9 months	ITT population includes all randomized participants.	events per 100-person years	NUMBER
SECONDARY	Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4	Baseline to Month 4	ITT population includes all randomized participants.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)	Baseline up to 21.9 months	ITT population includes all randomized participants.	mL/min/1.73 m^2	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)	Sotagliflozin	51	events per 100-person years
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)	Placebo	76.3	events per 100-person years
Total Number of Occurrences of HHF and Urgent HF Visits	Sotagliflozin	40.4	events per 100-person years
Total Number of Occurrences of HHF and Urgent HF Visits	Placebo	63.9	events per 100-person years
Total Number of Deaths From Cardiovascular Causes	Sotagliflozin	10.6	events per 100-person years
Total Number of Deaths From Cardiovascular Causes	Placebo	12.5	events per 100-person years
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke	Sotagliflozin	51.4	events per 100-person years
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke	Placebo	71.0	events per 100-person years
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized	Sotagliflozin	54.7	events per 100-person years
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized	Placebo	80.6	events per 100-person years

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sotagliflozin	608
Overall Study	STARTED	Placebo	614
Overall Study	Randomized and Treated	Sotagliflozin	605
Overall Study	Randomized and Treated	Placebo	611
Overall Study	COMPLETED	Sotagliflozin	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Sotagliflozin	608
Overall Study	NOT COMPLETED	Placebo	614

Source ClinicalTrials.gov

Adverse events584

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hypotension	Vascular disorders	Sotagliflozin	33	605
other	Hypotension	Vascular disorders	Placebo	27	611
other	Cardiac failure	Cardiac disorders	Sotagliflozin	41	605
other	Cardiac failure	Cardiac disorders	Placebo	57	611
other	Diarrhoea	Gastrointestinal disorders	Sotagliflozin	36	605
other	Diarrhoea	Gastrointestinal disorders	Placebo	18	611
serious	Aortic rupture	Vascular disorders	Sotagliflozin	0	605
serious	Aortic rupture	Vascular disorders	Placebo	1	611
serious	Arteriosclerosis	Vascular disorders	Sotagliflozin	1	605
serious	Arteriosclerosis	Vascular disorders	Placebo	0	611

1 to 10 of 584Source ClinicalTrials.gov

See all 584 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sotagliflozin	65	608
Total, all-cause mortality	Placebo	76	614
Total, other adverse events	Sotagliflozin	101	605
Total, other adverse events	Placebo	90	611
Total, serious adverse events	Sotagliflozin	235	605
Total, serious adverse events	Placebo	251	611

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33200892	DERIVED	PubMed
34152828	DERIVED	PubMed
38770818	DERIVED	PubMed
38771012	DERIVED	PubMed
38878007	DERIVED	PubMed
39260929	DERIVED	PubMed
42815751	DERIVED	PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sotagliflozin vs Placebo: deaths from any cause	Trial comparisons
Sotagliflozin vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03521934

GET https://conductscience.org/api/trials/v1/NCT03521934/events?page=2

API reference For AI assistants