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

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00622323
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-25
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide	12 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the change from baseline to endpoint in HbA1c and body weight of Filipino patients with type 2 diabetes mellitus treated with exenatide who are taking metformin and/or a sulfonylurea but have not achieved adequate glycemic control.	12 weeks

Trial Locations

Locations (1)

Research Site; 🇵🇭 Taytay, Philippines