Trial abstract · §3
AMPLITUDE-O — results
Primary endpoint, absolute and relative effect where derivable, and harms as reported.
§3Results
§3.1Primary endpoint
Table 3. Primary endpoint as reported.
| Endpoint | Result as reported | Certainty |
|---|---|---|
| Time to first major adverse cardiovascular event in type 2 diabetes with cardiovascular or kidney disease | Hazard ratio 0.73 (95 % CI 0.58 to 0.92), with a composite kidney outcome also reduced | Moderate |
| Reproduced from the published report. Where the report states a confidence interval the Institute reproduces it; where it does not, none is constructed. | ||
§3.2Endpoint hierarchy
Table 4. Relative and absolute effect. The Institute reports both, because a relative measure without a baseline risk cannot be acted on and systematically overstates benefit in lower-risk populations.
| Measure | Value | Note |
|---|---|---|
| Hazard ratio as reported | 0.73 | Reproduced from the published report. |
| Comparator event rate, % | 6.5 | Illustrative. A rate typical of the enrolled risk profile, used to convert the relative measure. Not a published figure. |
| Absolute risk difference, pp | 1.76 | Illustrative. Computed from the two rows above. |
| Number needed to treat | 57 | Illustrative. For the stated duration, at the comparator rate assumed above. Rises sharply as baseline risk falls. |
| Three of the four rows are Institute constructions and are marked. Only the hazard ratio is a published figure. | ||
§3.3Harms as reported
Table 5. Adverse events for Exenatide from the safety tables the Institute holds for this compound. Where a row names a different trial as its source, the figure is from that trial and not from this one.
| Event | Active, % | Comparator, % | Source trial |
|---|---|---|---|
| Nausea | 44.0 | 18.0 | AMIGO pooled (immediate release) |
| Vomiting | 13.0 | 4.0 | AMIGO pooled |
| Diarrhoea | 13.0 | 6.0 | AMIGO pooled |
| Injection-site nodule | — | — | A characteristic finding with the microsphere extended-release product, reported in up to 17 % and generally resolving over weeks to months |
| Acute pancreatitis | 0.2 | 0.1 | EXSCEL |
| Antibody formation | — | — | Higher than for human-sequence analogues, reflecting the non-human origin; high-titre antibodies attenuate efficacy in a minority |
| Discontinuation for adverse events | 8.0 | 3.0 | AMIGO pooled |
Compound Evidence Institute · CEI-TR-0094/3 · https://compoundevidence.com/trials/amplitude-o/results/ · retrieved 30 July 2026