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Clinical Trial Details

Trial ID: L4179
Source ID: NCT01652716
Associated Drug: Exenatide Once Weekly Suspension
Title: Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
Acronym: DURATION-NEO-1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01652716/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Exenatide once weekly suspension|DRUG: Exenatide twice daily
Outcome Measures: Primary: Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28, The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus., Baseline to Week 28 | Secondary: Percentage of Subjects Achieving HbA1c <7% at Week 28, Percentage of subjects achieving HbA1c \<7% at Week 28/Study Termination, Baseline to Week 28|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28, Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination, Baseline to Week 28|Change in Body Weight (kg) From Baseline to Week 28, Change in body weight (kg) from baseline to Week 28/Study Termination., Baseline to Week 28|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16, Change in 2-hour postprandial glucose concentrations from baseline to Week 16., Baseline to Week 16
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 377
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-01
Completion Date: 2014-08
Results First Posted: 2015-09-16
Last Update Posted: 2018-07-03
Locations: Research Site, Muscle Shoals, Alabama, 35662, United States|Research Site, Mesa, Arizona, 85206, United States|Research Site, Phoenix, Arizona, 85020, United States|Research Site, Little Rock, Arkansas, 72205, United States|Research Site, Escondido, California, 92026, United States|Research Site, Garden Grove, California, 92844, United States|Research Site, Lomita, California, 90717, United States|Research Site, Los Angeles, California, 90015, United States|Research Site, Santa Ana, California, 92705, United States|Research Site, Spring Valley, California, 91978, United States|Research Site, Walnut Creek, California, 94598, United States|Research Site, Denver, Colorado, 80220, United States|Research Site, Coral Gables, Florida, 33134, United States|Research Site, DeLand, Florida, 32720, United States|Research Site, Kissimmee, Florida, 34741, United States|Research Site, Miami, Florida, 33156, United States|Research Site, Orlando, Florida, 32806, United States|Research Site, Oviedo, Florida, 32765, United States|Research Site, Palm Harbor, Florida, 34684, United States|Research Site, Ponte Vedra, Florida, 32081, United States|Research Site, Chicago, Illinois, 60607, United States|Research Site, Chicago, Illinois, 60616, United States|Research Site, Lexington, Kentucky, 40503, United States|Research Site, Paducah, Kentucky, 42003, United States|Research Site, Lake Charles, Louisiana, 70601, United States|Research Site, Columbia, Maryland, 21045, United States|Research Site, Elkridge, Maryland, 21075, United States|Research Site, Hyattsville, Maryland, 20782, United States|Research Site, New Bedford, Massachusetts, 02740, United States|Research Site, Detroit, Michigan, 48202, United States|Research Site, Troy, Michigan, 48098, United States|Research Site, Edina, Minnesota, 55435, United States|Research Site, Port Gibson, Mississippi, 39150, United States|Research Site, Saint Louis, Missouri, 63128, United States|Research Site, Butte, Montana, 59701, United States|Research Site, Henderson, Nevada, 89052, United States|Research Site, Endwell, New York, 13760, United States|Research Site, New Windsor, New York, 12553, United States|Research Site, Greensboro, North Carolina, 27408, United States|Research Site, Cincinnati, Ohio, 45219, United States|Research Site, Cincinnati, Ohio, 45227, United States|Research Site, Columbus, Ohio, 43213, United States|Research Site, Oklahoma City, Oklahoma, 73103, United States|Research Site, Oklahoma City, Oklahoma, 73112, United States|Research Site, Portland, Oregon, 97239, United States|Research Site, Harleysville, Pennsylvania, 19438, United States|Research Site, Charleston, South Carolina, 29407, United States|Research Site, Mount Pleasant, South Carolina, 29464, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, Houston, Texas, 77062, United States|Research Site, San Antonio, Texas, 78205, United States|Research Site, Murray, Utah, 84123, United States|Research Site, Salt Lake City, Utah, 84107, United States|Research Site, Manassas, Virginia, 20110, United States|Research Site, Norfolk, Virginia, 23502, United States|Research Site, Richmond, Virginia, 23294, United States|Research Site, Olympia, Washington, 98502, United States|Research Site, Spokane, Washington, 99202, United States
URL: https://clinicaltrials.gov/show/NCT01652716

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress