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Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients
This study is currently recruiting participants.
Verified by Amylin Pharmaceuticals, Inc., May 2008
Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00622323
  Purpose

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
Type 2 Diabetes Mellitus

MedlinePlus related topics: Diabetes
Drug Information available for: Exenatide Metformin Metformin hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 300
Study Start Date: February 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622323

Contacts
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY(1-877-285-4559)

Locations
Philippines
Research Site Not yet recruiting
Paranaque City, Philippines
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY(1-877-285-4559)        
Research Site Recruiting
Pasig City, Philippines
Contact: Lilly Clinical Trial Support Center     1-877-CTLILLY(1-877-285-4559)        
Research Site Not yet recruiting
Taytay, Philippines
Contact: Lilly Clinical Trials Support Center     1-877-CTLILLY(1-877-285-4559)        
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers: H80-PH-B006, H80-PH-B006
Study First Received: February 14, 2008
Last Updated: May 8, 2008
ClinicalTrials.gov Identifier: NCT00622323  
Health Authority: Philippines: Department of Health;   Philippines: Bureau of Food and Drugs

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes
exenatide
metformin
sulfonylurea
Byetta
Amylin
Lilly

Study placed in the following topic categories:
Metabolic Diseases
Exenatide
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009