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

NCT01077323 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 363766

Last updated 2015-04-15

Study results available
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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.

Conditions

  • Type 2 Diabetes (Treated With Exenatide or Other Oral Antidiabetic Therapies)
  • Healthy Subjects (Treated With no Diabetes Therapies)

Interventions

DRUG

exenatide

subcutaneous injection, dosing according to normal clinical practice

DRUG

Other antidiabetic therapies

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

OTHER

No diabetes therapy

Subjects not diagnosed with diabetes

Sponsors & Collaborators

Principal Investigators

  • Vice President Research and Development, MD · Amylin Pharmaceuticals, LLC.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077323 on ClinicalTrials.gov