A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Exenatide and Other Antidiabetic Agents

NCT01077323 · Completed

Last updated 2026-05-28

This study looked back at medical records to compare the rates of acute pancreatitis in people with type 2 diabetes taking exenatide or other diabetes medications, as well as in healthy individuals not taking any diabetes treatments.

Status Completed The study has finished.

Type Observational

Participants 363,766 people

Who can join all sexes

Timeline Started 2004-09 · est. completion 2008-03

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01077323 ↗

Description as written by the study sponsor.

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.

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, dosing according to normal clinical practice
Other antidiabetic therapies Drug

Includes metformin, thiazolidinediones, insulins, sulfonylureas, non-sulfonylurea secretagogues, sitagliptin, and alpha-glucosidase inhibitors; In all cases, dosing according to normal clinical practice
No diabetes therapy Other

Subjects not diagnosed with diabetes

Main thing measured	Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During "Current Use" Period) - Time on Drug Analysis
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes (Treated With Exenatide or Other Oral Antidiabetic Therapies), Healthy Subjects (Treated With no Diabetes Therapies)
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01077323 ↗