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Clinical Trial Details

Trial ID: L3909
Source ID: NCT01077323
Associated Drug: Exenatide
Title: A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Exenatide and Other Antidiabetic Agents
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01077323/results
Conditions: Type 2 Diabetes (Treated With Exenatide or Other Oral Antidiabetic Therapies)|Healthy Subjects (Treated With no Diabetes Therapies)
Interventions: DRUG: exenatide|DRUG: Other antidiabetic therapies|OTHER: No diabetes therapy
Outcome Measures: Primary: Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Current Use" Period) - Time on Drug Analysis, Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is "current use" period, described as "time during current day's supply plus 31 days.", 43 months|Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among "Recent Use" Period) - Time on Drug Analysis, Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is the "recent use" period, described as "time following current use plus an additional 31 days excluding subsequent current use.", 43 months|Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Past Use" Period) - Time on Drug Analysis, Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is "past use" period, described as "time following recent use excluding subsequent current or recent use.", 43 months | Secondary: Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis Among Initiators of Exenatide, Diabetics Initiating Other Antidiabetic Drugs, and the Non-diabetes Cohort - Intent to Treat Analysis, Crude intent-to-treat incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort., 43 months
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company|i3 Drug Safety
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 363766
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2004-09
Completion Date: 2008-03
Results First Posted: 2010-10-06
Last Update Posted: 2015-04-15
Locations: Research Site, Waltham, Massachusetts, United States
URL: https://clinicaltrials.gov/show/NCT01077323