What happens next in GLP-1 — and when.

Trial results

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

NCT01191268 on ClinicalTrials.gov · last registry update 2014-10-08

An unusually large phase 3: 884 participants, more than double the 424 typical for the stage. The sponsor logged completion for February 2012. Primary outcome, as filed: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c). dulaglutide is already approved in the US for type 2 diabetes, so this is asking a further question rather than establishing the drug works at all.

Status
COMPLETED
Phase
P3
Drug
dulaglutide
Trulicity
Sponsor
Eli Lilly and Company
Sponsor type
Industry
Enrollment
884
Started
2010-11
Primary completion
2012-02 actual

Observed history

No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.

Primary outcome

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Conditions studied

Diabetes Mellitus, Type 2

Every field above is taken directly from the registry record. See all detected changes across the class, or the dulaglutide page for this molecule’s full trial and approval history.

@glp1briefing