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Clinical Trial Details

Trial ID: L2794
Source ID: NCT01928329
Associated Drug: Exenatide (Bydureon®)
Title: A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01928329/results
Conditions: Type I Diabetes
Interventions: DRUG: Exenatide (Bydureon®)|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in HbA1c Levels, 6 months | Secondary: Change From Baseline in HbA1c Levels, 12 months|Major Hypoglycemic Event Rate On Drug, The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL., Up to 6 months|Major Hypoglycemic Event Rate Off Drug, The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL., Up to 12 months
Sponsor/Collaborators: Sponsor: Yale University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 79
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-09
Completion Date: 2019-08
Results First Posted: 2019-10-22
Last Update Posted: 2020-03-19
Locations: University of California, San Francisco, San Francisco, California, United States|Barbara Davis Center, Aurora, Colorado, United States|Yale University, New Haven, Connecticut, United States|University of Miami, Miami, Florida, 33136, United States|University of Chicago, Chicago, Illinois, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Michigan, Ann Arbor, Michigan, 48105, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States
URL: https://clinicaltrials.gov/show/NCT01928329