Brief Summary

This trial is conducted in Asia. The aim of this trial is to evaluate safety and effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination with antidiabetes agents other than sulfonylurea under post-marketing normal clinical practice conditions.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,092

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach

1 country

5 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

December 15, 2014

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed

Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

December 17, 2014

Last Update Submit

August 31, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Number of AEs (adverse events)
Week 0-52

Secondary Outcomes (2)

Number of adverse reactions (ARs)
Week 0-52
Change in HbA1c (glycosylated haemoglobin)
Week 0, week 52

Study Arms (1)

Liraglutide

Drug: liraglutide

Interventions

liraglutideDRUG

Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions. No treatment given.

Liraglutide

Eligibility Criteria

Sexall

Healthy VolunteersNo

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

Sampling MethodNon-Probability Sample

Study Population

Male or female patients with T2DM who the physician has decided to start on treatment with Victoza® in combination with insulin or oral anti-diabetes drug (OAD) other than SU (Sulfonylurea) will be eligible for this study.

You may qualify if:

Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
Patients with T2DM (type 2 diabetes mellitus) who the physician has decided to start treatment with Victoza® in combination with insulin or OAD (oral anti-diabetes drug) other than SU (sulfonylurea)
Male or female, no age limitation

You may not qualify if:

Previous participation in this study or NN2211-3772 Participation is defined as informed consent obtained for this study or enrolment for NN2211-3772
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Patients who are on Victoza® or have previously been on Victoza® within 3 month before the enrolment

Contact the study team to confirm eligibility.