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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: | NCT00359762 |
This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: exenatide Drug: glimepiride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study) |
Estimated Enrollment: | 1054 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental |
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
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Group B: Active Comparator |
Drug: glimepiride
oral tablet (titrated to maximally tolerated dose), once daily
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: *insulin; *thiazolidinediones;
Study Director: | James Malone, MD | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
Study ID Numbers: | H8O-EW-GWBE |
Study First Received: | July 31, 2006 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00359762 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: The Italian Medicines Agency; Mexico: Ministry of Health; Poland: Ministry of Health; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
exenatide diabetes Amylin Lilly glimepiride |
Metabolic Diseases Immunologic Factors Exenatide Amylin Metformin Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents |
Immunosuppressive Agents Glimepiride Hypoglycemic Agents Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Exenatide Immunologic Factors Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents |
Pharmacologic Actions Glimepiride Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Glucose Metabolism Disorders |