Trial abstract · §3
PRAM-T1D-PIVOTAL — 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 |
|---|---|---|
| Change in glycated haemoglobin from baseline to week 52 added to mealtime insulin in type 1 diabetes | A modest glycaemic improvement with weight reduction and an increase in severe hypoglycaemia | 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
§3.3Harms as reported
Table 5. Adverse events for Pramlintide 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 | 48.0 | 16.0 | Type 1 diabetes pivotal |
| Anorexia | 17.0 | 2.0 | Pivotal pooled |
| Vomiting | 11.0 | 4.0 | Pivotal pooled |
| Severe hypoglycaemia | — | — | Boxed warning; incidence highest in the first four weeks and requires a prospective insulin dose reduction of 50 % at initiation |
| Injection-site reaction | — | — | Reported |
| Discontinuation for adverse events | 29.0 | — | Pivotal pooled — high |
Compound Evidence Institute · CEI-TR-0150/3 · https://compoundevidence.com/trials/pram-t1d-pivotal/results/ · retrieved 30 July 2026