SUSTAIN-6 — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, event-driven cardiovascular outcome trial
- Masking
- Double-blind with independent endpoint adjudication
- Arms
- 2
- Allocation
- Randomised between the intervention and its comparator
- Endpoint adjudication
- Independent, blinded to assignment
- Data monitoring
- Independent data monitoring committee with access to unblinded accumulating data
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Semaglutide | 1,714 | 52.0 % | Intervention at the dose reached after titration |
| Placebo | 1,583 | 48.0 % | Matched placebo, administered on the same schedule |
| Randomised total 3,297 as published. Arm-level splits are reconstructed and are not published figures. | |||
§2.3Population
Indications. Atherosclerotic cardiovascular disease and cardiovascular risk reduction · Type 2 diabetes mellitus
Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.
Geographic footprint. United States · United Kingdom · Denmark · Finland · Italy · Poland · Israel · Australia · New Zealand · Brazil · Argentina · China.
§2.4Eligibility as the Institute reads it
- Included. Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.
- Excluded. Participants for whom the intervention is contraindicated, including personal or family history of medullary thyroid carcinoma. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
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.