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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00516048




Registration number
NCT00516048
Ethics application status
Date submitted
10/08/2007
Date registered
14/08/2007
Date last updated
7/04/2015

Titles & IDs
Public title
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Scientific title
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Secondary ID [1] 0 0
H8O-MC-GWBO
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - exenatide

Experimental: Exenatide:Treatment-Emergent Antibody Negative - This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.

Experimental: Exenatide:Treatment-Emergent Antibody Positive - This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.


Treatment: Drugs: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
24 weeks
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
24 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
24 weeks

Eligibility
Key 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%.
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Research Site - Keswick
Recruitment postcode(s) [1] 0 0
- Keswick
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Hungary
State/province [5] 0 0
Gyula
Country [6] 0 0
Hungary
State/province [6] 0 0
Zalaegerszeg
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
Italy
State/province [8] 0 0
Perugia
Country [9] 0 0
Italy
State/province [9] 0 0
Rome
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seonnam City
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Suwon City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00516048
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chief Medical Officer, MD
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications