NCT00516048

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach
5 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 17, 2009

Completed
Last Updated

April 7, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

August 10, 2007

Results QC Date

April 29, 2009

Last Update Submit

March 19, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

exenatideByettaantibodiesAmylinLilly

Outcome Measures

Primary Outcomes (2)

  • 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)

    24 weeks

  • 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

    24 weeks

Secondary Outcomes (1)

  • Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

    24 weeks

Study Arms (2)

Exenatide:Treatment-Emergent Antibody Negative

EXPERIMENTAL

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

Drug: exenatide

Exenatide:Treatment-Emergent Antibody Positive

EXPERIMENTAL

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

Drug: exenatide

Interventions

exenatideDRUG

subcutaneous injection, 5mcg or 10mcg, twice a day

Also known as: Byetta, AC2993, LY2148568
Exenatide:Treatment-Emergent Antibody NegativeExenatide:Treatment-Emergent Antibody Positive

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Keswick, South Australia, Australia

Location

Research Site

Calgary, Alberta, Canada

Location

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

London, Ontario, Canada

Location

Research Site

Budapest, Hungary

Location

Research Site

Gyula, Hungary

Location

Research Site

Zalaegerszeg, Hungary

Location

Research Site

Milan, Italy

Location

Research Site

Perugia, Italy

Location

Research Site

Rome, Italy

Location

Research Site

Seonnam City, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Suwon, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Results Point of Contact

Title
Peter Ohman, Medical Science Director
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Chief Medical Officer, MD

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2007

First Posted

August 14, 2007

Study Start

August 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 7, 2015

Results First Posted

June 17, 2009

Record last verified: 2015-03

Locations

IT(3)HU(3)AU(1)KR(3)CA(3)