Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-08-31

Brief Summary

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This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

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Detailed Description

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This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. All patients will continue their current diet and exercise regimen during the study.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exenatide

The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy.

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.

Insulin

The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin will be taken according to the subject's current regimen

Interventions

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exenatide

Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.

Intervention Type DRUG

Insulin

Insulin will be taken according to the subject's current regimen

Intervention Type DRUG

Other Intervention Names

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synthetic exendin-4 AC2993 Byetta

Eligibility Criteria

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Inclusion Criteria

* Patients have been treated with insulin for \>=3 months up to 12 years.
* HbA1c \<=10.5%.
* Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.

Exclusion Criteria

* Patients previously received exenatide or GLP-1 analogs.
* Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No