Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Exenatide

Exenatide and the subject's current oral antidiabetic agent regimen

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week

Placebo

Placebo and the subject's current oral antidiabetic agent regimen

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week

Interventions

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exenatide

subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week

Intervention Type DRUG

Placebo

subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week

Intervention Type DRUG

Other Intervention Names

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Byetta AC2993 synthetic enxendin-4

Eligibility Criteria

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Inclusion Criteria

* Subject has an HbA1c between 7.0% and 10.0%, inclusive.
* Subject has a body mass index (BMI) \>25 kg/m\^2 and \<50 kg/m\^2.
* Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.

Exclusion Criteria

* Subject has been treated with any of the following medications: \*exogenous insulin for more than 1 week within 3 months of screening, \*sulfonylureas or meglitinides within 2 months of screening, \*alpha-glucosidase inhibitors within 2 months of screening, \*pramlintide acetate injection within 2 months of screening.
* Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No