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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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)
Timepoint [1] 0 0
24 weeks
Primary outcome [2] 0 0
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Timepoint [2] 0 0
24 weeks
Secondary outcome [1] 0 0
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
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
Sex
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- Have previously completed or withdrawn from this study.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
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
58
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00516048