Clinical trial NCT00622323: Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients
Official title: Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
metformin
sulfonylurea
Byetta
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2008-02-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients at least 18 years of age and diagnosed with type 2 diabetes mellitus treated in an ambulatory care setting and who are taking metformin, a sulfonylurea, or a combination of metformin and sulfonylurea, but have not achieved adequate glycemic control. Female patients eligible of becoming pregnant are required to have some form of contraception while participating in the study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Paranaque City
country: Philippines
facility: Research Site
city: Pasig City
country: Philippines
facility: Research Site
city: Taytay
country: Philippines
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References: