Dulaglutide in type 2 diabetes mellitus: durability of effect — amendment log
Every change made since protocol registration, with its date and reason.
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§5Amendment log
Every change made to this review after protocol registration is recorded below with its date and its reason. A change that is not in this log did not happen. The Institute publishes the log in full, including changes that did not alter a conclusion, because a reader cannot judge which changes matter unless all of them are visible.
§5.1Amendment log
Table 9. Amendments to this review since protocol registration.
| Date | Version | Amendment | Record |
|---|---|---|---|
| 14 Apr 2025 | 0.1 | Protocol registered | The review protocol was registered with the Institute’s secretariat before the search was executed. No change to the review question was made after registration. |
| 09 Sep 2025 | 2.1 | Study reclassified | A study previously included was reclassified as ineligible following retrieval of the full report. The quantitative synthesis was re-run without it. |
| 29 Dec 2025 | 3.2 | Analysis method changed | The pooling method was changed from a fixed-effect to a random-effects model following observation of between-study heterogeneity exceeding the pre-specified threshold. |
| 13 Apr 2026 | 3.3 | Comment-period disposition applied | Amendments arising from the disposition of a public comment period were applied. Each amendment is traceable to a numbered submission. |
| 07 Jul 2026 | 3.0 | Certainty rating revised | The certainty rating for one outcome was revised following the addition of a contributing study. The rationale is recorded in the certainty assessment section. |
| Current version 3.1, ratified in the 2025 Q3 assessment cycle. | |||
§5.2Clinical study report requests
Table 10. Clinical study reports requested for the contributing trials, and the outcome of each request. Refusals are recorded because a review that does not record them presents the sponsor's disclosure decision as the Institute's own.
| Trial | Requested | Outcome |
|---|---|---|
| AWARD-11 | 16 May 2025 | No response |
| REWIND | 07 Jun 2025 | Supplied on request |
| AWARD-7 | 08 May 2025 | Supplied on request |
| HARMONY-OUTCOMES | 21 May 2025 | Supplied on request |
| AWARD-1 | 02 Apr 2025 | Supplied on request |
| AWARD-5 | 02 Apr 2025 | No response |
| AWARD-6 | 06 Apr 2025 | Supplied on request |
§5.3Superseded versions
Superseded versions of this review remain published at a stable address, are marked as superseded, and link forward to the current version. The current version links back to each of them. That practice was adopted following a submission that a document cited in the literature must remain retrievable in the form in which it was cited; the reasoning is published on the corrections policy disposition page.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet 2019;394(10193):121–130. doi:10.1016/S0140-6736(19)31149-3 · PMID 31189511
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.