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

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Exenatide

U.S. FDA Resources

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

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

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

Amylin Pharmaceuticals, LLC.

Eli Lilly and Company

Investigators

Study Director:

Chief Medical Officer, MD

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Amylin Pharmaceuticals, LLC.
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:	April 24, 2013
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, LLC.:

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

ClinicalTrials.gov processed this record on May 23, 2013