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| Sponsors and Collaborators: |
Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
| Information provided by: | Amylin Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00135330 |
Purpose
This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.
| Condition | Intervention | Phase |
|
Diabetes Mellitus, Type 2 |
Drug: exenatide Drug: rosiglitazone |
Phase III |
| MedlinePlus related topics: | Diabetes |
| ChemIDplus related topics: | Exenatide Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin |
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2005 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
|
| 2: Experimental |
Drug: rosiglitazone
oral tablet, 2mg or 4mg, twice a day
|
| 3: Experimental |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Drug: rosiglitazone
oral tablet, 2mg or 4mg, twice a day
|
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Treated with any of the following medications:
Contacts and Locations| United States, Arizona | |||||
| Research Site | |||||
| Phoenix, Arizona, United States | |||||
| United States, California | |||||
| Research Site | |||||
| San Francisco, California, United States | |||||
| United States, Florida | |||||
| Research Site | |||||
| Orlando, Florida, United States | |||||
| Research Site | |||||
| Jacksonville, Florida, United States | |||||
| United States, Georgia | |||||
| Research Site | |||||
| Atlanta, Georgia, United States | |||||
| United States, Hawaii | |||||
| Research Site | |||||
| Honolulu, Hawaii, United States | |||||
| United States, Indiana | |||||
| Research Site | |||||
| Indianapolis, Indiana, United States | |||||
| United States, Massachusetts | |||||
| Research Site | |||||
| Boston, Massachusetts, United States | |||||
| Research Site | |||||
| Pittsfield, Massachusetts, United States | |||||
| United States, Minnesota | |||||
| Research Site | |||||
| Rochester, Minnesota, United States | |||||
| Research Site | |||||
| Minneapolis, Minnesota, United States | |||||
| United States, New York | |||||
| Research Site | |||||
| Bronx, New York, United States | |||||
| Research Site | |||||
| Syracuse, New York, United States | |||||
| United States, Ohio | |||||
| Research Site | |||||
| Cincinatti, Ohio, United States | |||||
| United States, Texas | |||||
| Research Site | |||||
| League City, Texas, United States | |||||
| Research Site | |||||
| San Antonio, Texas, United States | |||||
| Research Site | |||||
| New Braunfels, Texas, United States | |||||
| United States, Washington | |||||
| Research Site | |||||
| Renton, Washington, United States | |||||
| Research Site | |||||
| Spokane, Washington, United States | |||||
| Amylin Pharmaceuticals, Inc. |
| Eli Lilly and Company |
| Study Director: | James Malone, MD | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
| Study ID Numbers: | H8O-US-GWAY |
| First Received: | August 24, 2005 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00135330 |
| Health Authority: | United States: Food and Drug Administration |
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