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

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT00622323

H8O-PH-B006

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.