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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00622323
First received: February 14, 2008
Last updated: September 18, 2013
Last verified: September 2013
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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 ]

Enrollment: 41
Study Start Date: February 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (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

Locations
Philippines
Research Site
Paranaque City, Philippines
Research Site
Pasig City, Philippines
Research Site
Taytay, Philippines
Sponsors and Collaborators
Bristol-Myers Squibb
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00622323     History of Changes
Other Study ID Numbers: H80-PH-B006, H80-PH-B006
Study First Received: February 14, 2008
Last Updated: September 18, 2013
Health Authority: Philippines: Department of Health
Philippines: Bureau of Food and Drugs

Keywords provided by Bristol-Myers Squibb:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014