An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Information source: Amylin Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: exenatide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amylin Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company
Summary
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.
Clinical Details
Official title: An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To assess anti-exenatide-antibody response to exenatide re-exposure as measured by antibodies and incidence of allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide.
Secondary outcome: To evaluate the impact of anti-exenatide antibodies on patients' safety and efficacy, as assessed by the following:
*Incidence of the adverse events;
*Change in hemoglobin A1c (HbA1c)
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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- Have previously completed or withdrawn from this study.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.
Locations and Contacts
Research Site, Gyula, Hungary
Research Site, Budapest, Hungary
Research Site, Zalaegerszeg, Hungary
Research Site, Rome, Italy
Research Site, Perugia, Italy
Research Site, Milan, Italy
Research Site, Seoul, Korea, Republic of
Research Site, Seonnam City, Korea, Republic of
Research Site, Suwon City, Korea, Republic of
Research Site, Calgary, Alberta, Canada
Research Site, Vancouver, British Columbia, Canada
Research Site, London, Ontario, Canada
Research Site, Keswick, South Australia, Australia
Additional Information
Starting date: August 2007
Ending date: June 2008
Last updated: June 2, 2008
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