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Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients

NCT ID: NCT00622323

Last Updated: 2016-10-26

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

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-09-30

Brief Summary

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This is a prospective, non-interventional, post marketing surveillance study to determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, serious and non-serious, that would occur among Filipino patients with type 2 diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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diabetes exenatide metformin sulfonylurea Byetta Amylin Lilly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* are male or female outpatients at least 18 years of age
* provide written consent to the release of their data after being informed of the study
* diagnosed with type 2 diabetes mellitus and are taking metformin, or a sulfonylurea or both
* are reliable, and agree to keep all appointments for clinic visits, complete tests and procedures as may be required by the attending physician in the course of routine clinical care
* are treated with exenatide according to the approved Product Insert, as prescribed by the investigator in the routine care of the patient

Exclusion Criteria

* are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
* are currently taking insulin.
* are pregnant or have intentions of becoming pregnant within the duration of the study.
* are the investigators or their immediate families. Immediate family is defined as the investigator's spouse, parents, natural or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chief Medical Officer, MD

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Research Site

Paranaque City, , Philippines

Site Status

Research Site

Pasig, , Philippines

Site Status

Research Site

Taytay, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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H8O-PH-B006

Identifier Type: -

Identifier Source: secondary_id

H8O-PH-B006

Identifier Type: -

Identifier Source: org_study_id