Type 2 Diabetes MellitusPhase 3NCT00516048
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
A Phase 3 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 13 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Aug 2007to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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- Have previously completed or withdrawn from this study.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.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Canada3 sites
Research Site
Calgary, Alberta
Research Site
London, Ontario
Research Site
Vancouver, British Columbia
Hungary3 sites
Research Site
Budapest
Research Site
Gyula
Research Site
Zalaegerszeg
South Korea3 sites
Research Site
Seonnam City
Research Site
Seoul
Research Site
Suwon
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- exenatide
- Keywords
- exenatide, Byetta, antibodies, Amylin, Lilly
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exenatideDrug
Also called Byetta, AC2993, LY2148568
subcutaneous injection, 5mcg or 10mcg, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Exenatide:Treatment-Emergent Antibody Negative | Experimental | This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Receives: Drug: exenatide |
| Exenatide:Treatment-Emergent Antibody Positive | Experimental | This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Receives: Drug: exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 24 weeks
Secondary outcomes (1)
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, MD, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516048
- Sponsor's protocol ID
- H8O-MC-GWBO
- Status last verified
- Mar 2015
- First submitted
- 10 Aug 2007
- Last updated
- 7 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00516048
- Acronym / sponsor ID
- H8O-MC-GWBO
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- exenatide, Byetta, antibodies, Amylin, Lilly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Aug 2007 (estimated)
- Results
- Posted 17 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide:Treatment-Emergent Antibody Negative | Experimental | Drug: exenatideThis arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. |
| Exenatide:Treatment-Emergent Antibody Positive | Experimental | Drug: exenatideThis arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exenatideAlso: Byetta, AC2993, LY2148568subcutaneous injection, 5mcg or 10mcg, twice a day | Drug | Exenatide:Treatment-Emergent Antibody Negative, Exenatide:Treatment-Emergent Antibody Positive |
Primary outcome
Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
Time frame: 24 weeks
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
Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study
1 secondary outcome
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer, MD study director
Eli Lilly and Company
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, Hungary, Italy, South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent Antibody Status (Maximum Titer Level Experienced) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.