Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes

NCT ID: NCT01288326

Last Updated: 2017-01-26

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

254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-03-31

Brief Summary

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The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.

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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A

liraglutide

Intervention Type DRUG

Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.

Interventions

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liraglutide

Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs)

Exclusion Criteria

* Previously treated with liraglutide
* Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
* Pregnant, breast feeding or have the intention of becoming pregnant
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

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Buysschaert M, D'Hooge D, Preumont V; Roots Study Group. ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza(R)) in type 2 diabetic patients. Diabetes Metab Syndr. 2015 Jul-Sep;9(3):139-42. doi: 10.1016/j.dsx.2015.05.001. Epub 2015 May 8.

Reference Type RESULT
PMID: 26004030 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1116-2199

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-3876

Identifier Type: -

Identifier Source: org_study_id

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