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

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00516048

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 III

MedlinePlus related topics: Allergy Diabetes

Drug Information available for: Exenatide Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Exenatide Arm: Experimental 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

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

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
Gyula, Hungary
Research Site
Budapest, Hungary
Research Site
Zalaegerszeg, Hungary
Italy
Research Site
Rome, Italy
Research Site
Perugia, Italy
Research Site
Milan, Italy
Korea, Republic of
Research Site
Suwon City, Korea, Republic of
Research Site
Seonnam City, Korea, Republic of
Research Site
Seoul, Korea, Republic of

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

More Information

Responsible Party:	Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:	H8O-MC-GWBO
Study First Received:	August 10, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00516048
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 Amylin Pharmaceuticals, Inc.:

exenatide
Byetta
antibodies
Amylin
Lilly

Study placed in the following topic categories:

Antibodies
Metabolic Diseases
Exenatide
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Immunoglobulins

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009