Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure
Summary
Primary Objectives: * Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart failure, compared to placebo. Secondary Objectives: * Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
Timeline
- Start
- 2017-12-04
- Primary completion
- 2019-08-17
- Completion
- 2019-08-17
Outcome
Missed primary endpoint
Stopped: “1st two cohorts provided the required data, therefore 3rd cohort was not deemed necessary”
registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p = 0.736; Difference in Least Squares (LS) Means 1.26 (90% CI -5.4 to 7.93); ANCOVA NCT03292653 ↗
registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p = 0.184; Difference in LS Means -0.04 (90% CI -0.09 to 0.01); ANCOVA NCT03292653 ↗
registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p = 0.094; Difference in LS Means -17.07 (90% CI -33.79 to -0.35); ANCOVA NCT03292653 ↗
registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p = 0.4269; Difference in LS Means -4.82 (90% CI -15.45 to 5.8); ANCOVA NCT03292653 ↗
registry analysis (superiority test); Placebo vs Sotagliflozin 200 mg; p = 0.1761; Difference in LS Means 847.2 (90% CI -210.46 to 1904.86); ANCOVA NCT03292653 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotagliflozin | Small molecule | 200 mg | Oral |
| Subject | Sotagliflozin | Small molecule | 400 mg | Oral |