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

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ClinicalTrials.gov Identifier: NCT00622323
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease
Type 2 Diabetes Mellitus

Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients
Study Start Date : February 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622323


Locations
Philippines
Research Site
Paranaque City, Philippines
Research Site
Pasig City, Philippines
Research Site
Taytay, Philippines
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00622323     History of Changes
Other Study ID Numbers: H8O-PH-B006
H8O-PH-B006
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by AstraZeneca:
diabetes
exenatide
metformin
sulfonylurea
Byetta
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists