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

March 19, 2015 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Keswick, South Australia, Australia
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • London, Ontario, Canada
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • Italy
      • Milan, Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Rome, Italy
        • Research Site
  • Korea, Republic of
      • Seonnam City, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Suwon City, Korea, Republic of
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes.
  • Have been exposed to exenatide for at least 3 months in previous Amylin/Lilly Studies H8O-MC-GWAO, H8O-MC-GWAP, H8O-MC-GWAT, or H8O-MC-GWBA.
  • Have interrupted exenatide treatment for a period of at least 2 months.
  • HbA1c of ≤10.5%.

Exclusion Criteria:

  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Have previously completed or withdrawn from this study.
  • Have taken marketed exenatide (Byetta) during the interim period between studies GWAO, GWAP, GWAT, or GWBA and the current study.
  • Used drugs for weight loss (for example, Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], Accomplia® [rimonabant], or similar over-the-counter medications) within 3 months of screening.
  • Are currently treated with any of the following excluded medications: Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
  • Use insulin with daily dosage exceeding 1 U/kg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exenatide:Treatment-Emergent Antibody Negative
This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Names:
  • Byetta
  • AC2993
  • LY2148568
Experimental: Exenatide:Treatment-Emergent Antibody Positive
This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Names:
  • Byetta
  • AC2993
  • LY2148568

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
Time Frame: 24 weeks
Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)
24 weeks
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Time Frame: 24 weeks
Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Time Frame: 24 weeks
Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (Estimate)

August 14, 2007

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-MC-GWBO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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