Completed

Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes

A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

4,121

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•Serious AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01403025

Org study IDNN2211-3772

Secondary IDJapicCTI-111559JAPIC

Secondary IDU1111-1120-7575WHO

Timeline

Milestones

Study start2011-07-19actual

Study first posted2011-07-27estimated

Primary completion2015-12-28actual

Study completion2015-12-28actual

Last update posted2018-02-12actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who are considered to need treatment with liraglutide (Victoza®)

Inclusion criteria

•Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide

Exclusion criteria

•Subjects who are or have previously been on liraglutide

•Subjects who have previously been enrolled in the study

•Subjects with a hypersensitivity to liraglutide or to any of the excipients

•Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods

•Subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial

•Known or suspected abuse of alcohol or narcotics

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

The incidence of SADRs (Serious Adverse Drug Reactions)

Time frame:After 36 months

Serious AEs (any)

event count, event

Secondary/protocol endpoint

The incidence rate and type of SAEs (Serious Adverse Events)

Time frame:At month 1, 3, 6, 12, 24 and 36

Serious AEs (any)

event count, event

Secondary/protocol endpoint

The incidence rate and type of ADRs (Adverse Drug Reactions)

Time frame:At month 1, 3, 6, 12, 24 and 36

Treatment-emergent AEs (any)

descriptive, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.