Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

NCT ID: NCT02090673

Last Updated: 2015-08-20

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

1711 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-03-31

Brief Summary

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The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group1:Type 2 diabetic patients treated with Exenatide therapy

Korean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label

Exenatide

Intervention Type DRUG

Interventions

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Exenatide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female at least 18 years of age
* Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
* Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information

Exclusion Criteria

* Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
* Are pregnant or have intentions of becoming pregnant within the duration of the study
* Contraindications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Hwang YC, Kim A, Jo E, Yang Y, Cho JH, Lee BW. Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice. BMC Endocr Disord. 2017 Oct 25;17(1):68. doi: 10.1186/s12902-017-0220-4.

Reference Type DERIVED
PMID: 29065865 (View on PubMed)

Related Links

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Other Identifiers

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MB001-078

Identifier Type: -

Identifier Source: org_study_id

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