An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516048
• Other study ID #: H8O-MC-GWBO
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2007
• Last updated: March 19, 2015
• Start date: August 2007
• Est. completion date: April 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaHungary: National Institute of PharmacyItaly: Ministry of HealthSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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• Have previously completed or withdrawn from this study.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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day

Locations

Country	Name	City	State
Australia	Research Site	Keswick	South Australia
Canada	Research Site	Calgary	Alberta
Canada	Research Site	London	Ontario
Canada	Research Site	Vancouver	British Columbia
Hungary	Research Site	Budapest
Hungary	Research Site	Gyula
Hungary	Research Site	Zalaegerszeg
Italy	Research Site	Milan
Italy	Research Site	Perugia
Italy	Research Site	Rome
Korea, Republic of	Research Site	Seonnam City
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon City

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

Australia,  Canada,  Hungary,  Italy,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	24 weeks	No