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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
exenatide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring exenatide, Byetta, antibodies, Amylin, Lilly

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Have previously completed or withdrawn from this study.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.

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exenatide:Treatment-Emergent Antibody Negative

Exenatide:Treatment-Emergent Antibody Positive

Arm Description

This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.

This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.

Outcomes

Primary Outcome Measures

Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
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
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
Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status

Full Information

First Posted
August 10, 2007
Last Updated
March 19, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00516048
Brief Title
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Official Title
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
exenatide, Byetta, antibodies, Amylin, Lilly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide:Treatment-Emergent Antibody Negative
Arm Type
Experimental
Arm Description
This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.
Arm Title
Exenatide:Treatment-Emergent Antibody Positive
Arm Type
Experimental
Arm Description
This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta, AC2993, LY2148568
Intervention Description
subcutaneous injection, 5mcg or 10mcg, twice a day
Primary Outcome Measure Information:
Title
Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
Description
Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)
Time Frame
24 weeks
Title
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Description
Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Description
Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Keswick
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
Country
Hungary
Facility Name
Research Site
City
Milan
Country
Italy
Facility Name
Research Site
City
Perugia
Country
Italy
Facility Name
Research Site
City
Rome
Country
Italy
Facility Name
Research Site
City
Seonnam City
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon City
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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