AMPLITUDE-O — structured trial abstract

§1Structured abstract

§1.1Objective

To evaluate Exenatide in atherosclerotic cardiovascular disease and cardiovascular risk reduction and chronic kidney disease in type 2 diabetes 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

4,076

Duration of the primary analysis period

Median 1.8 years

Sponsor class

Manufacturer-sponsored

Registry identifier

not reproduced — see the note in §1.5

§1.3Primary endpoint

Time to first major adverse cardiovascular event in type 2 diabetes with cardiovascular or kidney disease

§1.4Principal result

Hazard ratio 0.73 (95 % CI 0.58 to 0.92), with a composite kidney outcome also reduced.

Efpeglenatide is an exendin-based long-acting agonist. The Institute holds no separate monograph for it and records the trial against the exenatide monograph, which covers the exendin-derived structural class. The result is material because it is the only positive cardiovascular outcome for an exendin-derived agent, and the neutral and borderline results for the other two agents in that structural class are the Institute’s principal reason for declining to treat cardiovascular benefit as a class effect.

§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.