Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
NCT ID: NCT02229383
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
464 participants
INTERVENTIONAL
2014-09-06
2016-08-29
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
DOUBLE
Study Groups
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Exenatide
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Exenatide
2 mg weekly suspension injection
Placebo
Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Exenatide matching placebo
Once weekly Placebo injection
Interventions
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Exenatide
2 mg weekly suspension injection
Exenatide matching placebo
Once weekly Placebo injection
Eligibility Criteria
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Inclusion Criteria
* Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).
* Has fasting plasma glucose (FPG) concentration \<280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)
* Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:
1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit
Exclusion Criteria
* History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
* Positive serological test for hepatitis B or hepatitis C
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Muscle Shoals, Alabama, United States
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Tempe, Arizona, United States
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Chino, California, United States
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Chula Vista, California, United States
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El Cajon, California, United States
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Fresno, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Tustin, California, United States
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West Hills, California, United States
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Boynton Beach, Florida, United States
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Brooksville, Florida, United States
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Chiefland, Florida, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, 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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Miami, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Columbus, Georgia, United States
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Chicago, Illinois, United States
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Avon, Indiana, United States
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Evansville, Indiana, United States
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Franklin, Indiana, United States
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Newton, Kansas, United States
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Monroe, Louisiana, United States
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New Orleans, Louisiana, United States
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Hazelwood, Missouri, United States
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Bellevue, Nebraska, United States
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Omaha, Nebraska, United States
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Haddon Heights, New Jersey, United States
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Mooresville, North Carolina, United States
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Morehead City, North Carolina, United States
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Morganton, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Medford, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Greer, South Carolina, United States
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Spartanburg, South Carolina, United States
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Dakota Dunes, South Dakota, United States
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Johnson City, Tennessee, United States
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Kingsport, Tennessee, United States
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Austin, Texas, United States
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Dallas, 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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Houston, Texas, United States
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Houston, Texas, United States
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Clinton, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Manassas, Virginia, United States
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Richmond, Virginia, United States
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Port Orchard, Washington, United States
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Baja, , Hungary
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Eger, , Hungary
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Gödöllő, , Hungary
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Gyula, , Hungary
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Komárom, , Hungary
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Létavértes, , Hungary
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Pécs, , Hungary
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Sátoraljaújhely, , Hungary
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Szeged, , Hungary
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Szekszárd, , Hungary
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Lodz, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Oświęcim, , Poland
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Poznan, , Poland
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Torun, , Poland
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Zamość, , Poland
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Zgierz, , Poland
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Baia Mare, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Galati, , Romania
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Oradea, , Romania
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Oradea, , Romania
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Ploieşti, , Romania
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Tg Mures, , Romania
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Timișoara, , Romania
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Dolný Kubín, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Levice, , Slovakia
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Lučenec, , Slovakia
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Nitra, , Slovakia
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Nitra, , Slovakia
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Prešov, , Slovakia
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Štúrovo, , Slovakia
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Bloemfontein, , South Africa
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Kempton Park, , South Africa
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Krugersdorp, , South Africa
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Paarl, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Somerset West, , South Africa
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Worcester, , South Africa
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.
Guja C, Frias JP, Somogyi A, Jabbour S, Wang H, Hardy E, Rosenstock J. Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study. Diabetes Obes Metab. 2018 Jul;20(7):1602-1614. doi: 10.1111/dom.13266. Epub 2018 Mar 25.
Other Identifiers
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2014-003502-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5553C00002
Identifier Type: -
Identifier Source: org_study_id
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