Clinical trial NCT00516048: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide
Byetta
antibodies
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-08-14
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* Have previously completed or withdrawn from this study.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.

Primary outcomes:
measure: Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
timeFrame: 24 weeks
measure: Incidence of Potentially Immune-related Treatment-emergent Adverse Events
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Keswick
country: Australia
facility: Research Site
state: South Australia
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: London
country: Canada
facility: Research Site
state: Ontario
city: Budapest
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Seonnam City
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon City
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References: