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Clinical Trial Details

Trial ID: L2417
Source ID: NCT00516048
Associated Drug: Exenatide
Title: An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00516048/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: exenatide
Outcome Measures: Primary: Treatment-emergent Antibody Status (Maximum Titer Level Experienced), Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced), 24 weeks|Incidence of Potentially Immune-related Treatment-emergent Adverse Events, Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study, 24 weeks | Secondary: Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint, Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status, 24 weeks
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 58
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-08
Completion Date: 2008-04
Results First Posted: 2009-06-17
Last Update Posted: 2015-04-07
Locations: Research Site, Keswick, South Australia, Australia|Research Site, Calgary, Alberta, Canada|Research Site, Vancouver, British Columbia, Canada|Research Site, London, Ontario, Canada|Research Site, Budapest, Hungary|Research Site, Gyula, Hungary|Research Site, Zalaegerszeg, Hungary|Research Site, Milan, Italy|Research Site, Perugia, Italy|Research Site, Rome, Italy|Research Site, Seonnam City, Korea, Republic of|Research Site, Seoul, Korea, Republic of|Research Site, Suwon City, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT00516048

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress