Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients
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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 |
- 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 ]
- 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 |
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.
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| Philippines | |
| Research Site | |
| Paranaque City, Philippines | |
| Research Site | |
| Pasig City, Philippines | |
| Research Site | |
| Taytay, Philippines | |
| Study Director: | Chief Medical Officer, MD | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| 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: | February 22, 2013 |
| Health Authority: | Philippines: Department of Health Philippines: Bureau of Food and Drugs |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
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 May 22, 2013