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Sponsors and Collaborators: |
Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
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Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00622323 |
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 |
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Type 2 Diabetes Mellitus |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients |
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) |
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:
Exclusion Criteria:
Contact: Lilly Clinical Trials Support Center | 1-877-CTLILLY(1-877-285-4559) |
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) |
Study Director: | James Malone, MD | Eli Lilly and Company |
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 |
diabetes exenatide metformin sulfonylurea |
Byetta Amylin Lilly |
Metabolic Diseases Exenatide Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |