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Sponsors and Collaborators: |
Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00359879 |
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
Condition | Intervention | Phase |
Type 2 Diabetes |
Drug: exenatide |
Phase III |
MedlinePlus related topics: | Diabetes |
Drug Information available for: | Exenatide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy |
Estimated Enrollment: | 400 |
Study Start Date: | September 2006 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
|
2: Active Comparator |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |||||
Research Site | |||||
Sao Paulo, Brazil | |||||
Research Site | |||||
Rio de Janeiro, Brazil | |||||
Research Site | |||||
Curitiba, Brazil | |||||
Research Site | |||||
Sao Jose Do Rio Preto, Brazil | |||||
Research Site | |||||
Fortaleza, Brazil | |||||
Research Site | |||||
Goiania, Brazil | |||||
Research Site | |||||
Campinas, Brazil | |||||
Research Site | |||||
Porto Alegre, Brazil | |||||
Research Site | |||||
Salvador, Brazil | |||||
Mexico | |||||
Research Site | |||||
Mexico City, Mexico | |||||
Research Site | |||||
Aguascalientes, Mexico | |||||
Research Site | |||||
San Luis Potosi, Mexico | |||||
Mexico, Jalisco | |||||
Research Site | |||||
Guadalajara, Jalisco, Mexico | |||||
Mexico, Nuevo Leon | |||||
Research Site | |||||
Monterrey, Nuevo Leon, Mexico | |||||
Mexico, Yucatan | |||||
Research Site | |||||
Merida, Yucatan, Mexico |
Amylin Pharmaceuticals, Inc. |
Eli Lilly and Company |
Study Director: | James Malone, MD | Eli Lilly and Company |
Link to study results on ClinicalStudyResults.org 
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Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
Study ID Numbers: | H8O-CR-GWBH |
First Received: | August 1, 2006 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00359879 |
Health Authority: | Mexico: Ministry of Health; Brazil: Ministry of Health |
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