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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00516048
First received: August 10, 2007
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Treatment-emergent Antibody Status (Maximum Titer Level Experienced) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)

  • Incidence of Potentially Immune-related Treatment-emergent Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study


Secondary Outcome Measures:
  • Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status


Enrollment: 58
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516048

Locations
Australia, South Australia
Research Site
Keswick, South Australia, Australia
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
London, Ontario, Canada
Hungary
Research Site
Budapest, Hungary
Research Site
Gyula, Hungary
Research Site
Zalaegerszeg, Hungary
Italy
Research Site
Milan, Italy
Research Site
Perugia, Italy
Research Site
Rome, Italy
Korea, Republic of
Research Site
Seonnam City, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon City, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00516048     History of Changes
Other Study ID Numbers: H8O-MC-GWBO
Study First Received: August 10, 2007
Results First Received: April 29, 2009
Last Updated: June 6, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by AstraZeneca:
exenatide
Byetta
antibodies
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014