Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

18+ years

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00622323

Start Date

February 1 2008

End Date

September 1 2009

Last Update

October 26 2016

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Research Site

Paranaque City, Philippines

2

Research Site

Pasig, Philippines

3

Research Site

Taytay, Philippines