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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: exenatide

• Registration Number: NCT00516048
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-10
• Study First Submitted QC: 2007-08-10
• Study First Posted: 2007-08-14
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-29
• Results First Submitted QC: 2009-04-29
• Results First Posted: 2009-06-17
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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%.

Read More

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• Have previously completed or withdrawn from this study.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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of Potentially Immune-related Treatment-emergent Adverse Events	24 weeks	Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study
Treatment-emergent Antibody Status (Maximum Titer Level Experienced)	24 weeks	Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint	24 weeks	Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status

Trial Locations

Locations (1)

Research Site; 🇰🇷 Suwon City, Korea, Republic of