Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)

NCT ID: NCT02321878

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1092 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-15

Study Completion Date

2017-06-16

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liraglutide

liraglutide

Intervention Type DRUG

Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions.

No treatment given.

Interventions

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liraglutide

Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions.

No treatment given.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Chichibu, , Japan

Site Status

Novo Nordisk Investigational Site

Koriyama-shi, Fukushima, , Japan

Site Status

Novo Nordisk Investigational Site

Oyama-shi, Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Tagajō-shi, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1157-6701

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-4175

Identifier Type: -

Identifier Source: org_study_id

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