NCT01821846|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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN2211-3929U1111-1132-2221

Study Type

observational

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2013

StartedNov 2013

CompletionMar 2017

Brief Summary

This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

First Submitted

Initial submission to the registry

March 27, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed

8 months until next milestone

Study Start

First participant enrolled

November 20, 2013

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2017

Completed

Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

March 27, 2013

Last Update Submit

August 18, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

The incidence of SADRs (Serious Adverse Drug Reactions)
Up to 6 months

Secondary Outcomes (4)

HbA1c (Glycosylated haemoglobin) change
Month 0, month 6
Percentage of subjects reaching the target of HbA1c below 7.0%
Month 6
Change in body weight
Month 0, month 6
Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions)
Up to 6 months

Study Arms (1)

Liraglutide

Drug: liraglutide

Interventions

liraglutideDRUG

Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm).

Liraglutide

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Victoza® will be prescribed and titrated by the physician.

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.