Dulaglutide official document review · version 1
This page preserves this version's findings, scope and source pins. Open the current profile →
Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
The original efficacy program focused on glycemic control
EMA’s 2014 review found HbA1c reductions across trials with different background therapies and comparators. Changes from baseline and between-group differences are different measures; they should not be pooled into a single headline effect. EMA PDF pp. 165, 166 ↗
More findings, study links and document coverage
Long exposure was much less common than any exposure
The phase 2/3 program included 4,006 participants exposed to dulaglutide, but only 642 for at least 78 weeks and 157 for at least 104 weeks. EMA identified this as a limitation for a treatment intended for chronic use. EMA PDF pp. 168 ↗
Background therapy changes the safety context
The review reports substantially greater hypoglycemia risk when dulaglutide was studied alongside insulin or a sulfonylurea. Comparing raw adverse-event rates without the accompanying regimen can mislead. EMA PDF pp. 168 ↗
This historical review precedes later evidence
The 2014 assessment described a cardiovascular outcomes trial as ongoing. It should be read alongside subsequent outcome studies and the separate 2022 pediatric FDA source note, not treated as the latest statement of all available evidence. EMA PDF pp. 169 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 22 inventoried documents; 21 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
Selected English EMA PDFs from the retained September 15, 2026 title-matched document feed, plus independently retrieved FDA approval-package documents where listed. Candidate entries are not verified product/application matches. This is a bounded inventory, not a complete FDA, national or worldwide source search. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Trulicity : EPAR - Public assessment report ↗
Selected sections reviewed · ema-29560 · Document/feed date: 2014-12-19
PDF identity verified independently of the feed. Selected sections reviewed; historical findings are not a current prescribing summary.
Verified: Trulicity · EMEA/H/C/002825 · Document dated 2014-09-25. Identity checked on PDF pp. 1, 2.
Identity and selected clinical design, efficacy, safety and benefit-risk sections only. One-based PDF file pages; unlisted pages have not been appraised. The date identifies the selected review within any compiled approval package.
Retrieved 2026-09-19. Read PDF pages: 1, 2, 165, 166, 167, 168, 169 of 172. SHA-256:
87d3ed40c84f3e768d08baa718d5fb6da45337587585acba88defb4c453b72af.Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity-H-C-PSUSA-10311-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation ↗
Not yet reviewed · ema-3547 · Document/feed date: 2017-07-04
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity : EPAR - Medicine overview ↗
Not yet reviewed · ema-7481 · Document/feed date: 2023-03-16
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation ↗
Not yet reviewed · ema-15349 · Document/feed date: 2016-12-15
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity : EPAR - All Authorised presentations ↗
Not yet reviewed · ema-28747 · Document/feed date: 2021-05-19
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity : EPAR - Risk-management-plan summary ↗
Not yet reviewed · ema-33131 · Document/feed date: 2023-03-16
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
CHMP summary of positive opinion for Trulicity ↗
Not yet reviewed · ema-35491 · Document/feed date: 2014-09-26
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Trulicity-H-C-PSUSA-00010311-201709 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation ↗
Not yet reviewed · ema-39535 · Document/feed date: 2018-07-17
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
CHMP post-authorisation summary of positive opinion for Trulicity (II-40) ↗
Not yet reviewed · ema-45471 · Document/feed date: 2019-09-20
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Trulicity-H-C-2825-II-0040 : EPAR - Assessment report - Variation ↗
Not yet reviewed · ema-45943 · Document/feed date: 2019-11-08
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity-H-C-2825-X-0045 : EPAR - Assessment report - Variation ↗
Not yet reviewed · ema-50024 · Document/feed date: 2021-02-01
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity-H-C-PSUSA-10311-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) ↗
Not yet reviewed · ema-51787 · Document/feed date: 2021-07-05
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
CHMP post-authorisation summary of opinion for Trulicity (II-65) ↗
Not yet reviewed · ema-57411 · Document/feed date: 2023-01-27
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Trulicity-H-C-2825-II-0065 : EPAR - Assessment report - Variation ↗
Not yet reviewed · ema-58037 · Document/feed date: 2023-03-16
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
P/0409/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M06) ↗
Not yet reviewed · ema-57625 · Document/feed date: 2023-02-13
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
P/0175/2020: EMA decision of 13 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M05) ↗
Not yet reviewed · ema-50586 · Document/feed date: 2021-03-16
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
P/0227/2016: EMA decision of 26 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M04) ↗
Not yet reviewed · ema-14233 · Document/feed date: 2016-06-27
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
P/0017/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M03) ↗
Not yet reviewed · ema-12783 · Document/feed date: 2016-03-29
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
P/0105/2015: EMA decision of 29 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity) (EMEA-000783-PIP01-09-M02) ↗
Not yet reviewed · ema-31033 · Document/feed date: 2015-05-19
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Trulicity : EPAR - Procedural steps taken and scientific information after authorisation (archive) ↗
Not yet reviewed · ema-3409 · Document/feed date: 2026-01-30
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity : EPAR - Procedural steps taken and scientific information after authorisation ↗
Not yet reviewed · ema-72360 · Document/feed date: 2026-01-30
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Trulicity : EPAR - Product information ↗
Not yet reviewed · ema-11584 · Document/feed date: 2026-01-30
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/002825.
Remaining work
- Read the later REWIND regulatory assessment and additional indication/strength variations.
- Reconcile the pediatric memo’s prose/table discrepancy before publishing a pooled HbA1c point estimate.