An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT00135330
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
137 participants
INTERVENTIONAL
2005-10-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exenatide Arm
exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Exenatide plus Rosiglitazone Arm
exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
rosiglitazone
oral tablet, 2mg or 4mg, twice a day
Rosiglitazone Arm
rosiglitazone
oral tablet, 2mg or 4mg, twice a day
Interventions
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exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
rosiglitazone
oral tablet, 2mg or 4mg, twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 25 kg/m\^2 to 40 kg/m\^2, inclusive.
Exclusion Criteria
* Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.
* Treated with any of the following medications:
* Thiazolidinedione within 5 months of screening;
* Sulfonylurea within 3 months of screening;
* Metformin/sulfonylurea combination therapy within 3 months of screening;
* Alpha-glucosidase inhibitor within 3 months of screening;
* Meglitinide within 3 months of screening;
* Insulin for more than 1 week within the 3 months prior to screening.
* Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time
* Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
* Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer
* Systemic antineoplastic agent
* Systemic transplantation medication
* Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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James Malone, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
San Francisco, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Pittsfield, Massachusetts, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Rochester, Minnesota, United States
Research Site
Syracuse, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
League City, Texas, United States
Research Site
New Braunfels, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Renton, Washington, United States
Research Site
Spokane, Washington, United States
Countries
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References
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Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
DeFronzo RA, Triplitt C, Qu Y, Lewis MS, Maggs D, Glass LC. Effects of exenatide plus rosiglitazone on beta-cell function and insulin sensitivity in subjects with type 2 diabetes on metformin. Diabetes Care. 2010 May;33(5):951-7. doi: 10.2337/dc09-1521. Epub 2010 Jan 27.
Other Identifiers
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H8O-US-GWAY
Identifier Type: -
Identifier Source: org_study_id
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