What happens next in GLP-1 — and when.

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Trial results

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)

NCT00905255 on ClinicalTrials.gov · last registry update 2016-12-21

A small phase 3 — 69 participants, against a typical 424. Completed January 2011. lixisenatide 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. The registry entry has been edited 1 time since then.

Status
COMPLETED
Phase
P3
Drug
lixisenatide
Soliqua, Adlyxin
Sponsor
Sanofi
Sponsor type
Industry
Enrollment
69
Started
2009-05
Primary completion
2011-01 actual

Observed history

Every change this record has made since we started watching it. ClinicalTrials.gov shows only the current value. When a field is edited the previous one is overwritten and nothing is published to say so, so this history exists only because someone was recording it at the time.

DetectedChangeDetail
2026-08-21First seen in registryRegistered as COMPLETED, P3

Primary outcome

Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring

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 lixisenatide page for this molecule’s full trial and approval history.