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Completed

Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus

A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

7

Recruiting sites

Enrollment

64

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

SADRs

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 IDNCT01821846
Org study IDNN2211-3929
Secondary IDU1111-1132-2221WHO

Timeline

Milestones

Study first posted2013-04-01estimated
Study start2013-11-20actual
Primary completion2017-03-08actual
Study completion2017-03-08actual
Last update posted2017-08-21actual

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

Victoza® will be prescribed and titrated by the physician.

Inclusion criteria

Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician
Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information

Exclusion criteria

Subjects with a hypersensitivity to Victoza® 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 personal or family history of medullary thyroid carcinoma (MTC)
Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)

Endpoints (5)

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.

Coverage by outcome category

Glycemic / diabetes
2
Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:Month 0, month 6

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

HbA1c (Glycosylated haemoglobin) change

Time frame:Month 0, month 6

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of subjects reaching the target of HbA1c below 7.0%

Time frame:Month 6

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

The incidence of SADRs (Serious Adverse Drug Reactions)

Time frame:Up to 6 months

event count, event

Secondary/protocol endpoint

Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions)

Time frame:Up to 6 months

Serious AEs (any)

event count, event

componentsSerious AEs (any)

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.