A Phase 3 interventional study of Sotagliflozin and Placebo in Heart Failure, Type 2 Diabetes Mellitus and Chronic Kidney Diseases, sponsored by Lexicon Pharmaceuticals. Terminated at 754 sites in 45 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.
Sponsored by Lexicon Pharmaceuticals · Phase 3, Interventional, and Prevention
Among 2,156 studies in Heart Failure with a site in United States — 348 open to participants now, 437 under way, 27 of them phase 3. Heart Failure · United States.
Among the 2,156 studies in Heart Failure with a site in United States, this one is the 11th largest by enrollment of the 1,600 interventional ones that give a count, is one of 123 that started in 2017, is one of 147 in phase 3, and was the 1,207th registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
Browse Heart Failure studies →348 of the 2,156 studies in Heart Failure with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Mayo Clinic · Sites in United States
Mayo Clinic · Sites in United States
Tufts Medical Center · Sites in United States
Stanford University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,156 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 174 · Phase 2 312 · Phase 3 177 · Phase 4 139
First in 1983; this study’s year is marked. 123 started in 2017.
This study's enrollment of 10,584 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 65 across the 1,600 interventional studies, 150 across the 551 observational. Of the 1,509 that completed or were terminated, 629 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
745 of 2,156 have an industry lead sponsor. The 10 most frequent:
Lexicon Pharmaceuticals is the lead sponsor of 61 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
Lexicon Pharmaceuticals has 3 studies filed under Heart Failure — fewer than ten, so there is no comparison to draw.
136 of the studies in Heart Failure with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02901184Phase 3Uppsala UniversitySpironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction | 2026-12 |
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Among the 2,156 studies in Heart Failure with a site in United States, from their registry updates:
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The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 6 months to 400 mg, for up to 28.9 months.
Drug: Sotagliflozin
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 6 months to matching placebo to sotagliflozin 400 mg, for up to 29.6 months.
Drug: Placebo
Sotagliflozin was administered as a tablet(s), orally once daily.
Also known as: SAR439954
Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
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.
Time frame: Up to 30 months
Total Number of Occurrences of HHF and Urgent HF Visits
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.
Time frame: Up to 30 months
Number of Deaths From Cardiovascular Causes
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time frame: Up to 30 months
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
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 randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time frame: Up to 30 months
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomization of HHF, urgent HF visits, CV Death, and HF while hospitalized. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time frame: Up to 30 months
Number of Occurrences After Randomization of the Composite of Sustained ≥50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for ≥30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for ≥30 Days)
Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time frame: Up to 30 months
Number of Deaths From Any Cause
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Time frame: Up to 30 months
Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death 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.
Time frame: Up to 30 months
Participants took part in the study at 723 study centers in North America, Latin America, Western Europe, Eastern Europe, and the Rest of the World from 19 December 2017 to 08 July 2020.
| Milestone | Sotagliflozin | Placebo |
|---|---|---|
| Started | 5292 | 5292 |
| Randomized and treated | 5291 | 5286 |
| Completed | 0 | 0 |
| Not completed | 5292 | 5292 |
| Withdrew: Death | 240 | 246 |
| Withdrew: Withdrawal by subject | 57 | 68 |
| Withdrew: Site terminated by sponsor | 256 | 282 |
| Withdrew: Study terminated by sponsor | 4723 | 4664 |
| Withdrew: Reason not specified | 16 | 32 |
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.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF) | 5.6 | 7.5 |
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.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Total Number of Occurrences of HHF and Urgent HF Visits | 3.5 | 5.1 |
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Number of Deaths From Cardiovascular Causes | 2.2 | 2.4 |
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 randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke | 7.6 | 10.4 |
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomization of HHF, urgent HF visits, CV Death, and HF while hospitalized. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized | 6.4 | 8.3 |
Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Number of Occurrences After Randomization of the Composite of Sustained ≥50% Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline (for ≥30 Days), Chronic Dialysis, Renal Transplant, or Sustained eGFR <15 mL/Min/1.73 m^2 (for ≥30 Days) | 0.5 | 0.7 |
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Number of Deaths From Any Cause | 3.5 | 3.5 |
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death 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.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Total Number of Occurrences of CV Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 4.8 | 6.3 |
Collected over First dose of study drug up to 10 days after the last dose of study drug (Up to 30 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sotagliflozin | 246/5,292 (4.6%) | 1,236/5,291 (23.4%) | 705/5,291 (13.3%) |
| Placebo | 246/5,292 (4.6%) | 1,331/5,286 (25.2%) | 609/5,286 (11.5%) |
| Event | Sotagliflozin | Placebo |
|---|---|---|
| Cardiac failureCardiac disorders | 94/5291 | 147/5286 |
| Acute kidney injuryRenal and urinary disorders | 61/5291 | 52/5286 |
| Acute myocardial infarctionCardiac disorders | 48/5291 | 59/5286 |
| PneumoniaInfections and infestations | 37/5291 | 57/5286 |
| Myocardial infarctionCardiac disorders | 24/5291 | 55/5286 |
| Angina unstableCardiac disorders | 44/5291 | 52/5286 |
| Cardiac failure congestiveCardiac disorders | 23/5291 | 46/5286 |
| Pneumonia bacterialInfections and infestations | 17/5291 | 39/5286 |
| Ischaemic strokeNervous system disorders | 29/5291 | 36/5286 |
| Atrial fibrillationCardiac disorders | 34/5291 | 35/5286 |
| Event | Sotagliflozin | Placebo |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 380/5291 | 395/5286 |
| DiarrhoeaGastrointestinal disorders | 373/5291 | 253/5286 |
Intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group.
| Age, Continuous(years) | Sotagliflozin | Placebo | Total |
|---|---|---|---|
| Mean | 68.4 ± 8.4 | 68.2 ± 8.4 | 68.3 ± 8.4 |
| Sex: Female, Male(Participants) | Sotagliflozin | Placebo | Total |
|---|---|---|---|
| Female | 2347 | 2407 | 4754 |
| Male | 2945 | 2885 | 5830 |
| Ethnicity (NIH/OMB)(Participants) | Sotagliflozin | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1671 | 1678 | 3349 |
| Not Hispanic or Latino | 3593 | 3581 | 7174 |
| Unknown or Not Reported | 28 | 33 | 61 |
| Race (NIH/OMB)(Participants) | Sotagliflozin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 205 | 216 | 421 |
| Asian | 317 | 365 | 682 |
| Native Hawaiian or Other Pacific Islander | 25 | 15 | 40 |
| Black or African American | 176 | 187 | 363 |
| White | 4383 | 4329 | 8712 |
| More than one race | 129 | 114 | 243 |
| Unknown or Not Reported | 57 | 66 | 123 |
Showing the first 100 of 754 sites across 45 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Ran from Dec 2017 to primary completion in Jul 2020, 30 months.
Results were first posted in Oct 2022, 2 years 3 months after primary completion. A results delay was requested in Oct 2020.
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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sotagliflozin