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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622323
• Other study ID #: H8O-PH-B006
• Secondary ID: H8O-PH-B006
• Status: Completed
• Phase: N/A
• First received: February 14, 2008
• Last updated: October 25, 2016
• Start date: February 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of HealthPhilippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Philippines	Research Site	Paranaque City
Philippines	Research Site	Pasig City
Philippines	Research Site	Taytay

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Lilly Clinical Trial Registry