STEP-HFpEF-DM — structured trial abstract
STEP-HFpEF-DM — Semaglutide in hfpef and type 2 diabetes: randomised, double-blind, placebo-controlled
§1Structured abstract
§1.1Objective
To evaluate Semaglutide in heart failure with preserved ejection fraction and obesity and type 2 diabetes mellitus, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Phase
- Phase 3
- Randomised participants
- 616
- Duration of the primary analysis period
- 52 weeks
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Change in the Kansas City Cardiomyopathy Questionnaire clinical summary score and percentage change in body weight in participants with type 2 diabetes
§1.4Principal result
Directionally consistent with STEP-HFpEF with a smaller weight effect, as expected in a population with diabetes.[1]
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Extracted | Reproduced as published. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Kosiborod MN, Abildstrøm SZ, Borlaug BA, Butler J, Rasmussen S, Davies M, Hovingh GK, Kitzman DW, Lindegaard ML, Møller DV, Shah SJ, Treppendahl MB, Verma S, Abhayaratna W, Ahmed FZ, Chopra V, Ezekowitz J, Fu M, Ito H, Petrie MC. Semaglutide in patients with heart failure with preserved ejection fraction and obesity. New England Journal of Medicine 2023;389(12):1069–1084. doi:10.1056/NEJMoa2306963 · PMID 37622681
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.