SCALE-PREDIABETES — structured trial abstract
SCALE-PREDIABETES — Liraglutide in prediabetes and obesity: randomised, double-blind, placebo-controlled
§1Structured abstract
§1.1Objective
To evaluate Liraglutide in prediabetes and progression to type 2 diabetes and obesity and overweight in adults, 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
- 2,254
- Duration of the primary analysis period
- 160 weeks
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Time to onset of type 2 diabetes over three years in participants with prediabetes
§1.4Principal result
Onset in 2 % versus 6 % with placebo; hazard ratio 0.21 (95 % CI 0.13 to 0.34).
The only trial in the Institute’s set that reports incident diabetes as a randomised outcome of a weight-management agent.
§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. |