Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00516048Other idH8O-MC-GWBO

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 58 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Not randomized · Open label (no masking)
Countries: 5 countries
Australia, Canada, Hungary, Italy, South Korea
Start: Aug 2007
Primary completion: Apr 2008
Completion: Apr 2008
First posted: 14 Aug 2007 (estimated)
Last update posted: 7 Apr 2015 (estimated)
Conditions: Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200720082009

Ph 3
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
NCT00516048
Aug 2007 to Apr 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

exenatideDrug

Arms2

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.

Primary outcomes2

Outcomes the sponsor listed as primary.

Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
Time frame · 24 weeks
Registry description
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
Registry description
Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study

Secondary outcomes(1)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 24 weeks

Treatment-emergent Antibody Status (Maximum Titer Level Experienced)

Group	Value (Participants)
Exenatide:Treatment-Emergent Antibody Negative	15
Exenatide: Treatment-Emergent Antibody Positive	0
Enrolled But Withdrew Before Receiving Treatment	0

Primary outcomeNumber· 24 weeks

Incidence of Potentially Immune-related Treatment-emergent Adverse Events

Group	Value (participants)
Exenatide:Treatment-Emergent Antibody Negative	1
Exenatide: Treatment-Emergent Antibody Positive	0
Enrolled But Withdrew Before Receiving Treatment	0

Secondary and other outcome results(1)

Secondary outcomeMean· 24 weeks

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

Group	Value (percent)	Spread
Exenatide:Treatment-Emergent Antibody Negative	8.13	0.66
Exenatide: Treatment-Emergent Antibody Positive	8.05	1.00
Enrolled But Withdrew Before Receiving Treatment	0	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exenatide:Treatment-Emergent Antibody Negative5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.	–	0 / ?	7 / ?
Exenatide: Treatment-Emergent Antibody Positive5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.	–	1 / ?	11 / ?
Enrolled But Withdrew Before Receiving TreatmentNo exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.	–	1 / ?	0 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 20 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.