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Clinical Trial Details

Trial ID: L2736
Source ID: NCT01652729
Associated Drug: Exenatide Once Weekly Suspension
Title: 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
Acronym: DURATION-NEO-2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01652729/results
Conditions: Diabetes Type 2
Interventions: DRUG: Exenatide once weekly suspension|DRUG: Sitagliptin|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28, Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests., Baseline to Week 28 | Secondary: Percentage of Subjects Achieving HbA1c <7% at Week 28, Percentage of subjects achieving HbA1c target values of \< 7.0% at Week 28/Study Termination., Baseline to Week 28|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28, The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination., Baseline to Week 28|Change in Body Weight (kg) From Baseline to Week 28, The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination., Baseline to Week 28|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8), The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (\< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate., Baseline to Week 16
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 365
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-02
Completion Date: 2014-04
Results First Posted: 2015-04-23
Last Update Posted: 2015-08-20
Locations: Research Site, Birmingham, Alabama, 35216, United States|Research Site, Huntsville, Alabama, 35801, United States|Research Site, Phoenix, Arizona, 85018, United States|Research Site, Phoenix, Arizona, 85020, United States|Research Site, Beverly Hills, California, 90036, United States|Research Site, Buena Park, California, 90620, United States|Research Site, Chino, California, 91710, United States|Research Site, Chula Vista, California, 91910, United States|Research Site, Encinitas, California, 92024, United States|Research Site, Greenbrae, California, 94904, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Los Angeles, California, 90059, United States|Research Site, North Hollywood, California, 91606, United States|Research Site, Walnut Creek, California, 94598, United States|Research Site, West Hills, California, 91307, United States|Research Site, Boca Raton, Florida, 33432, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Miami, Florida, 33143, United States|Research Site, Miami, Florida, 33169, United States|Research Site, Miami, Florida, 33183, United States|Research Site, Port Orange, Florida, 32127, United States|Research Site, St. Petersburg, Florida, 33709, United States|Research Site, Chicago, Illinois, 60607, United States|Research Site, Evanston, Illinois, 60201, United States|Research Site, Indianapolis, Indiana, 46254, United States|Research Site, Oxon Hill, Maryland, 20745, United States|Research Site, Omaha, Nebraska, 68130, United States|Research Site, Henderson, Nevada, 89052, United States|Research Site, Las Vegas, Nevada, 89101, United States|Research Site, Las Vegas, Nevada, 89123, United States|Research Site, Albuquerque, New Mexico, 87102, United States|Research Site, Buffalo, New York, 14215, United States|Research Site, Hartsdale, New York, 10530, United States|Research Site, Charlotte, North Carolina, 28204, United States|Research Site, Clayton, North Carolina, 27520, United States|Research Site, Durham, North Carolina, 27710, United States|Research Site, Greensboro, North Carolina, 27410, United States|Research Site, Mooresville, North Carolina, 28117, United States|Research Site, Salisbury, North Carolina, 28144, United States|Research Site, Cincinnati, Ohio, 45246, United States|Research Site, Franklin, Ohio, 45005, United States|Research Site, Marion, Ohio, 43302, United States|Research Site, Yukon, Oklahoma, 73099, United States|Research Site, Eugene, Oregon, 97404, United States|Research Site, Portland, Oregon, 97210, United States|Research Site, Greer, South Carolina, 29651, United States|Research Site, Simpsonville, South Carolina, 29681, United States|Reseach Site, Rapid City, South Dakota, 57702, United States|Research Site, Chattanooga, Tennessee, 37421, United States|Research Site, Carrolton, Texas, 75007, United States|Research Site, Corpus Christi, Texas, 78404, United States|Research Site, Dallas, Texas, 75390, United States|Research Site, Houston, Texas, 77072, United States|Research Site, Houston, Texas, 77074, United States|Research Site, Katy, Texas, 77450, United States|Research Site, San Antonio, Texas, 78205, United States|Research Site, Salt Lake City, Utah, 84095, United States|Research Site, Salt Lake City, Utah, 84107, United States|Research Site, Burke, Virginia, 22015, United States|Research Site, Spokane, Washington, 99202, United States
URL: https://clinicaltrials.gov/show/NCT01652729

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress