SURPASS-4 — structured trial abstract
SURPASS-4 — Tirzepatide in type 2 diabetes and cardiovascular: randomised, open-label, active-controlled
§1Structured abstract
§1.1Objective
To evaluate Tirzepatide in type 2 diabetes mellitus and atherosclerotic cardiovascular disease and cardiovascular risk reduction, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, open-label, active-controlled, parallel-group
- Masking
- Open-label with blinded endpoint adjudication
- Phase
- Phase 3
- Randomised participants
- 2,002
- Duration of the primary analysis period
- Median 85 weeks
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Change in glycated haemoglobin from baseline to week 52, tirzepatide versus insulin glargine, in participants at increased cardiovascular risk
§1.4Principal result
Superior glycaemic control; cardiovascular events were collected and adjudicated but the trial was not powered for a cardiovascular outcome.
§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. |