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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00622323

Enrollment

Registered

2008-02-25

Start date

2008-02-29

Completion date

2009-09-30

Last updated

2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, exenatide, metformin, sulfonylurea, Byetta, Amylin, Lilly

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Philippines

Outcome results