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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exenatide:Treatment-Emergent Antibody Negative

This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

subcutaneous injection, 5mcg or 10mcg, twice a day

Exenatide:Treatment-Emergent Antibody Positive

This arm will receive 5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks.

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

subcutaneous injection, 5mcg or 10mcg, twice a day

Interventions

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exenatide

subcutaneous injection, 5mcg or 10mcg, twice a day

Intervention Type DRUG

Other Intervention Names

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Byetta AC2993 LY2148568

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No