Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes

NCT ID: NCT01403025

Last Updated: 2018-02-12

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

4121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-19

Study Completion Date

2015-12-28

Brief Summary

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This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).

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

Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm

Interventions

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liraglutide

Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide

Exclusion Criteria

* Subjects who are or have previously been on liraglutide
* Subjects who have previously been enrolled in the study
* Subjects with a hypersensitivity to liraglutide 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 cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial
* Known or suspected abuse of alcohol or narcotics
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

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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U1111-1120-7575

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-111559

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN2211-3772

Identifier Type: -

Identifier Source: org_study_id

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