Phase 3 · Exenatide

NCT00516048 trial results

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

Participants: 58
Status: completed
Completed: 2008-04
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT00516048), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00516048 measured first

Treatment-emergent Antibody Status (Maximum Titer Level Experienced)Participants · 24 weeks · number

Measure	Exenatide:Treatment-Emergent Antibody Negativen=15	Exenatide: Treatment-Emergent Antibody Positiven=42
Antibody negative	15	0
Low titer antibodies	0	25
Higher titer antibodies	0	17

Incidence of Potentially Immune-related Treatment-emergent Adverse Eventsparticipants · 24 weeks · number

Measure	Exenatide:Treatment-Emergent Antibody Negativen=15	Exenatide: Treatment-Emergent Antibody Positiven=42
Arthralgia	1	0
Spinal osteoarthritis	1	0
Injection site pruritis	0	2
Injection site rash	0	1
Rash	0	1
Eye allergy	0	1

Side effects by arm

Side effects in NCT00516048

Percent of participants affected. The most common events the registry lists.

Event	Exenatide:Treatment-Emergent Antibody Negative	Exenatide: Treatment-Emergent Antibody Positive	Enrolled But Withdrew Before Receiving Treatment
Nasopharyngitis	6.7%	4.8%	0%
Diarrhoea	6.7%	2.4%	0%
Arthralgia	6.7%	0%	0%
Gastrooesphageal reflux disease	6.7%	0%	0%
Hyperglycaemia	6.7%	0%	0%
Otitis externa	6.7%	0%	0%
Otitis media	6.7%	0%	0%
Periodontitis	6.7%	0%	0%
Spinal osteoarthritis	6.7%	0%	0%
Vomiting	6.7%	0%	0%
Influenza	0%	4.8%	0%
Injection site pruritis	0%	4.8%	0%
Toothache	0%	4.8%	0%
Viral infection	0%	4.8%	0%

Secondary outcomes

What else it measured

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpointpercent · 24 weeks · mean

Measure	Exenatide:Treatment-Emergent Antibody Negativen=15	Exenatide: Treatment-Emergent Antibody Positiven=42	Enrolled But Withdrew Before Receiving Treatmentn=1
Baseline HbA1c (Week 0)	8.13(0.66)	8.05(1.00)	0(0)
Change in HbA1c at endpoint (Week 24)	-1.03(0.74)	-0.30(0.94)	0(0)

The trial

How NCT00516048 was run

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.

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

Who could join the trial

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.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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