STRIDE — structured trial abstract
STRIDE — Semaglutide in peripheral arterial disease and type 2 diabetes: randomised, double-blind, placebo-controlled
§1Structured abstract
§1.1Objective
To evaluate Semaglutide in peripheral arterial disease with intermittent claudication 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
- 792
- 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
Ratio to baseline of maximum walking distance on a constant-load treadmill at week 52
§1.4Principal result
Estimated treatment ratio 1.13 (95 % CI 1.06 to 1.21).
A functional endpoint in a population able to perceive its own weight change; the Institute downgrades one level for risk of bias on that ground.
§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. |