Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT01652729
Last Updated: 2015-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
365 participants
INTERVENTIONAL
2013-02-28
2014-04-30
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 once weekly suspension
Exenatide once weekly suspension 2mg subcutaneous injection
Exenatide once weekly suspension
Sitagliptin 100mg
Overencapsulated Sitagliptin 100mg oral tablet once daily
Sitagliptin
Placebo
Placebo oral capsule once daily
Placebo
Placebo oral capsule once daily
Interventions
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Exenatide once weekly suspension
Sitagliptin
Placebo
Placebo oral capsule once daily
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes mellitus
* HbA1c of 7.1% to 11.0%, inclusive, at screening
* Has stable body weight, i.e., not varying by \>3% for at least 3 months prior to screening
* Fasting plasma glucose concentration \<280 mg/dL (15.5 mmol/L) at screening
* Body mass index of \<45 kg/m2 at screening
* Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)
Exclusion Criteria
* Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
* History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance \<50 mL/min
* Active cardiovascular disease
* Presence or history of severe congestive heart failure
* Central nervous system disease, including epilepsy
* Liver disease
* History of severe gastrointestinal diseases
* Clinically significant malignant disease
* Repeated severe hypoglycemia within the last 6 months
* Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
* Any DPP-4 inhibitor within 3 months prior screening
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Ohman
Role: STUDY_CHAIR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
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Beverly Hills, California, United States
Research Site
Buena Park, California, United States
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Chino, California, United States
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Chula Vista, California, United States
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Encinitas, California, United States
Research Site
Greenbrae, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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North Hollywood, California, United States
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Walnut Creek, California, United States
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West Hills, California, United States
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Boca Raton, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Port Orange, Florida, United States
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St. Petersburg, Florida, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Indianapolis, Indiana, United States
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Oxon Hill, Maryland, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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Hartsdale, New York, United States
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Charlotte, North Carolina, United States
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Clayton, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Mooresville, North Carolina, United States
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Salisbury, North Carolina, United States
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Cincinnati, Ohio, United States
Research Site
Franklin, Ohio, United States
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Marion, Ohio, United States
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Yukon, Oklahoma, United States
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Eugene, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Greer, South Carolina, United States
Research Site
Simpsonville, South Carolina, United States
Reseach Site
Rapid City, South Dakota, United States
Research Site
Chattanooga, Tennessee, United States
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Carrolton, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
Research Site
Burke, Virginia, United States
Research Site
Spokane, Washington, United States
Countries
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References
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Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
Gadde KM, Vetter ML, Iqbal N, Hardy E, Ohman P; DURATION-NEO-2 study investigators. Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study. Diabetes Obes Metab. 2017 Jul;19(7):979-988. doi: 10.1111/dom.12908. Epub 2017 Mar 17.
Related Links
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Other Identifiers
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MB001-004
Identifier Type: OTHER
Identifier Source: secondary_id
BCB120
Identifier Type: -
Identifier Source: org_study_id
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