A Phase 3 interventional study of Sotagliflozin and Placebo in Heart Failure and Type 2 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals. Terminated at 466 sites in 32 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-10-28.
Sponsored by Lexicon Pharmaceuticals · Phase 3, Interventional, and Treatment
Primary Objective:
To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF)
Secondary Objectives:
To compare the effects of sotagliflozin to placebo on:
The estimated study duration for a given participants will be approximately 3 to 24 months.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
Drug: Sotagliflozin
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
Drug: Placebo
Pharmaceutical form: tablet Route of administration: oral
Also known as: SAR439954
Pharmaceutical form: tablet Route of administration: oral
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 21.9 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 21.9 months
Total 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 21.9 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 randomisation. 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 21.9 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 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.
Time frame: Up to 21.9 months
Total 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 21.9 months
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at 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.
Time frame: Baseline to Month 4
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
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.
Time frame: Baseline up to 21.9 months
Participants took part in the study at 306 investigative sites in North America, Latin America, Western Europe, Eastern Europe, and the Rest of the World from 15 June 2018 to 05 June 2020.
| Milestone | Sotagliflozin | Placebo |
|---|---|---|
| Started | 608 | 614 |
| Randomized and treated | 605 | 611 |
| Completed | 0 | 0 |
| Not completed | 608 | 614 |
| Withdrew: Death | 65 | 73 |
| Withdrew: Withdrawal by subject | 18 | 23 |
| Withdrew: Site terminated by sponsor | 39 | 35 |
| Withdrew: Study terminated by sponsor | 483 | 477 |
| Withdrew: Reason not specified | 3 | 6 |
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) | 51 | 76.3 |
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 | 40.4 | 63.9 |
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 |
|---|---|---|
| Total Number of Deaths From Cardiovascular Causes | 10.6 | 12.5 |
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.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke | 51.4 | 71.0 |
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.
| events per 100-person years | Sotagliflozin | Placebo |
|---|---|---|
| Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized | 54.7 | 80.6 |
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 |
|---|---|---|
| Total Number of Deaths From Any Cause | 13.5 | 16.3 |
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.
| score on a scale | Sotagliflozin | Placebo |
|---|---|---|
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4 | 17.7 ± 0.41 | 13.6 ± 0.41 |
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.
| mL/min/1.73 m^2 | Sotagliflozin | Placebo |
|---|---|---|
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | -0.34 ± 1.33 | -0.18 ± 1.33 |
Collected over First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sotagliflozin | 65/608 (10.7%) | 235/605 (38.8%) | 101/605 (16.7%) |
| Placebo | 76/614 (12.4%) | 251/611 (41.1%) | 90/611 (14.7%) |
| Event | Sotagliflozin | Placebo |
|---|---|---|
| Cardiac failureCardiac disorders | 80/605 | 121/611 |
| PneumoniaInfections and infestations | 19/605 | 26/611 |
| Cardiac failure congestiveCardiac disorders | 11/605 | 16/611 |
| Acute kidney injuryRenal and urinary disorders | 11/605 | 16/611 |
| Cardiac failure acuteCardiac disorders | 12/605 | 11/611 |
| Spinal cord ischaemia SyncopeNervous system disorders | 2/605 | 12/611 |
| Ischaemic strokeNervous system disorders | 9/605 | 9/611 |
| Sudden cardiac deathGeneral disorders | 7/605 | 9/611 |
| Myocardial infarctionCardiac disorders | 6/605 | 9/611 |
| Angina unstableCardiac disorders | 8/605 | 1/611 |
| Event | Sotagliflozin | Placebo |
|---|---|---|
| Cardiac failureCardiac disorders | 41/605 | 57/611 |
| DiarrhoeaGastrointestinal disorders | 36/605 | 18/611 |
| HypotensionVascular disorders | 33/605 | 27/611 |
Intent-to-treat (ITT) population included all randomized participants.
| Age, Continuous(years) | Sotagliflozin | Placebo | Total |
|---|---|---|---|
| Mean | 68.6 ± 9.5 | 69.3 ± 8.8 | 68.9 ± 9.1 |
| Sex: Female, Male(Participants) | Sotagliflozin | Placebo | Total |
|---|---|---|---|
| Female | 198 | 214 | 412 |
| Male | 410 | 400 | 810 |
| Ethnicity (NIH/OMB)(Participants) | Sotagliflozin | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 163 | 157 | 320 |
| Not Hispanic or Latino | 438 | 455 | 893 |
| Unknown or Not Reported | 7 | 2 | 9 |
| Race (NIH/OMB)(Participants) | Sotagliflozin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 7 | 15 |
| Native Hawaiian or Other Pacific Islander | 1 | 3 | 4 |
| Black or African American | 25 | 25 | 50 |
| White | 567 | 572 | 1139 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 6 | 6 | 12 |
Showing the first 100 of 466 sites across 32 countries.
Documents are hosted by the registry — open the source record to download them.
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.
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Lexicon Pharmaceuticals