Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
Summary
To assess the efficacy and safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes
Timeline
- Start
- 2020-10-13
- Primary completion
- 2022-05-03
- Completion
- 2022-05-03
Outcome
Missed primary endpoint
Stopped: “Trial prematurely terminated on 03 May 2022 due to the results from an interim analysis indicating a lack of efficacy in the study population.”
registry analysis (superiority test); DS102 4000mg vs Placebo; p = 0.1148124; Hodges Lehmann Median 8.24 (95% CI -2.01 to 18.19); Wilcoxon (Mann-Whitney) NCT04365400 ↗
registry analysis (superiority test); DS102 2000mg vs Placebo; p = 0.8668467; Hodges Lehmann Median -0.82 (95% CI -10.16 to 7.96); Wilcoxon (Mann-Whitney) NCT04365400 ↗
registry analysis (superiority test); DS102 4000mg vs Placebo; p = 0.8658; Difference in Change in HbA1c (%) 0.02516 (95% CI -0.26658 to 0.316897); ANCOVA NCT04365400 ↗
registry analysis (superiority test); DS102 2000mg vs Placebo; p = 0.6500; Difference in Change in HbA1c (%) -0.07333 (95% CI -0.39012 to 0.243455); ANCOVA NCT04365400 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DS102 | Unknown | 1000 mg | Oral |
| Subject | DS102 | Unknown | 2000 mg | Oral |