SUSTAIN-6 — structured trial abstract
SUSTAIN-6 — Semaglutide in cardiovascular and type 2 diabetes: event-driven cardiovascular outcome trial
§1Structured abstract
§1.1Objective
To evaluate Semaglutide in atherosclerotic cardiovascular disease and cardiovascular risk reduction 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, event-driven cardiovascular outcome trial
- Masking
- Double-blind with independent endpoint adjudication
- Phase
- Phase 3
- Randomised participants
- 3,297
- Duration of the primary analysis period
- 104 weeks
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Time to first occurrence of a three-point major adverse cardiovascular event composite
§1.4Principal result
Hazard ratio 0.74 (95 % CI 0.58 to 0.95); designed to exclude harm rather than to establish benefit.[1]
A pre-approval safety trial powered for non-inferiority. Retinopathy complications were more frequent with semaglutide in participants with pre-existing retinopathy and rapid glycaemic improvement, and the Institute reproduces that finding wherever the trial is cited.
§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.
- Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. New England Journal of Medicine 2016;375(19):1834–1844. doi:10.1056/NEJMoa1607141 · PMID 27633186
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.