Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes

NCT ID: NCT01345734

Last Updated: 2018-12-11

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

1056 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-01

Study Completion Date

2013-07-26

Brief Summary

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This trial is conducted in Asia. The aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.

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 will be prescribed and titrated by the treating physician and will be self-administered by the subject s.c. (under the skin) once daily. Study participants being treated with GLP-1 (Glucagon-Like Peptide 1)agonists or DDP-4-inhibitors (Dipeptidyl-peptidase 4 ) should stop treatment when initiating liraglutide treatment.

Interventions

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liraglutide

Liraglutide will be prescribed and titrated by the treating physician and will be self-administered by the subject s.c. (under the skin) once daily. Study participants being treated with GLP-1 (Glucagon-Like Peptide 1)agonists or DDP-4-inhibitors (Dipeptidyl-peptidase 4 ) should stop treatment when initiating liraglutide treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects or those already receiving other anti-diabetic medications including GLP-1 analogues other than Liraglutide, who require treatment with liraglutide according to the clinical judgment of their treating physician
* Subjects who are capable of giving study-specific signed informed consent before any collection of information

Exclusion Criteria

* Subjects with type 1 diabetes
* Subjects who are or have previously been on liraglutide
* Subjects who are participating in another clinical trial
* Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
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

Manila, , Philippines

Site Status

Countries

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Philippines

References

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Jimeno C, Kho S, de Los Santos GK, Buena-Bobis N, Villa M. The Multicenter, Open-Label, Observational LEAD-Ph Study: Real-World Safety and Effectiveness of Liraglutide in Filipino Participants with Type 2 Diabetes. J ASEAN Fed Endocr Soc. 2018;33(2):114-123. doi: 10.15605/jafes.033.02.02. Epub 2018 Oct 9.

Reference Type RESULT
PMID: 33442116 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1119-8803

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-3932

Identifier Type: -

Identifier Source: org_study_id