CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 363,766 enrolled
Drug / intervention
exenatide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01077323
NCT01077323N/ACompleted
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A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Byetta (Exenatide) and Other Antidiabetic Agents

AstraZeneca·observational·Posted Mar 1, 2010·Updated Apr 15, 2015

In Brief

An observational study evaluating exenatide, Other antidiabetic therapies, and 1 other intervention for Type 2 Diabetes (Treated With Exenatide or Other Oral Antidiabetic Therapies) and Healthy Subjects (Treated With no Diabetes Therapies). Completed, enrolled 363,766 participants across 1 site.

Detailed Summary

The purpose of this research was to assess the absolute and relative incidence of acute pancreatitis in persons initiating exenatide compared with persons initiating a different antidiabetic agent, and secondarily, persons without diabetes. This protocol summarizes a retrospective cohort study using eligibility, pharmacy claims, and medical claims data from a large US health plan affiliated with i3 Drug Safety.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes (Treated With Exenatide or Other Oral Antidiabetic Therapies), Healthy Subjects (Treated With no Diabetes Therapies)
CountriesUnited States
CollaboratorsEli Lilly and Company, i3 Drug Safety

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2010
Enrollment StartSep 1, 2004
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.3 years ago

Interventions

exenatidedrug

subcutaneous injection, dosing according to normal clinical practice

Other antidiabetic therapiesdrug

Includes metformin, thiazolidinediones, insulins, sulfonylureas, non-sulfonylurea secretagogues, sitagliptin, and alpha-glucosidase inhibitors; In all cases, dosing according to normal clinical practice

No diabetes therapyother

Subjects not diagnosed with diabetes