An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

NCT00516048 · Completed

Last updated 2026-05-28

This study tested how stopping the diabetes medication exenatide affects patients with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 58 people

Who can join Ages 20+ · all sexes

Timeline Started 2007-08 · est. completion 2008-04

Where 13 sites · Australia, Canada, Hungary, Italy, South Korea

What this study is testing ClinicalTrials.gov NCT00516048 ↗

Description as written by the study sponsor.

The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide.

Treatments tested

exenatide also known as Byetta, AC2993, LY2148568 Drug

subcutaneous injection, 5mcg or 10mcg, twice a day

Main thing measured	Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00516048 ↗