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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

1

Recruiting sites

Enrollment

4,121

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

Serious AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

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 1, 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 1, 2026 snapshot.