Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
NCT ID: NCT01652716
Last Updated: 2018-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
377 participants
INTERVENTIONAL
2013-01-31
2014-08-31
Brief Summary
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To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.
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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 once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
Exenatide twice daily (BID)
Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
Exenatide twice daily
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Interventions
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Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
Exenatide twice daily
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes mellitus
* HbA1c 7.1 to 11%, inclusive, at screening
* Fasting plasma glucose \<280 mg/dL (15.5 mmol/L)
* Body mass index (BMI) \<=45 kg/m2, inclusive, at screening
* Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents
Exclusion Criteria
* Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
* Active cardiovascular disease
* Presence of congestive heart failure
* Liver disease
* History of severe gastrointestinal diseases
* Repeated severe hypoglycemia within the last 6 months
* Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
* Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Vice President Medical Research & Development, M.D.
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Muscle Shoals, Alabama, United States
Research Site
Mesa, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Escondido, California, United States
Research Site
Garden Grove, California, United States
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Lomita, California, United States
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Los Angeles, California, United States
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Santa Ana, California, United States
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Spring Valley, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Coral Gables, Florida, United States
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DeLand, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Oviedo, Florida, United States
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Palm Harbor, Florida, United States
Research Site
Ponte Vedra, Florida, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Lexington, Kentucky, United States
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Paducah, Kentucky, United States
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Lake Charles, Louisiana, United States
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Columbia, Maryland, United States
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Elkridge, Maryland, United States
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Hyattsville, Maryland, United States
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New Bedford, Massachusetts, United States
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Detroit, Michigan, United States
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Troy, Michigan, United States
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Edina, Minnesota, United States
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Port Gibson, Mississippi, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Henderson, Nevada, United States
Research Site
Endwell, New York, United States
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New Windsor, New York, United States
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Greensboro, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Harleysville, Pennsylvania, United States
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Charleston, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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Salt Lake City, Utah, United States
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Manassas, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Olympia, Washington, United States
Research Site
Spokane, Washington, United States
Countries
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References
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Wysham CH, Rosenstock J, Vetter ML, Wang H, Hardy E, Iqbal N. Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e000773. doi: 10.1136/bmjdrc-2019-000773.
Wysham CH, Rosenstock J, Vetter ML, Dong F, Ohman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):165-172. doi: 10.1111/dom.13056. Epub 2017 Aug 22.
Other Identifiers
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MB001-003
Identifier Type: OTHER
Identifier Source: secondary_id
BCB118
Identifier Type: -
Identifier Source: org_study_id
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