Study Examining Exenatide Long-Acting Release in Subjects 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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-10-31

Brief Summary

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Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.

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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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Group A1

Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg

Group A2

Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg

Group B

Exenatide lead-in followed by exenatide LAR 0.8 mg weekly

Group Type EXPERIMENTAL

Exenatide LAR

Intervention Type DRUG

Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.

Group C

Exenatide lead-in followed by exenatide LAR 2.0 mg weekly

Group Type EXPERIMENTAL

Exenatide LAR

Intervention Type DRUG

Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.

Interventions

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placebo

Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg

Intervention Type DRUG

placebo

Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg

Intervention Type DRUG

Exenatide LAR

Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.

Intervention Type DRUG

Exenatide LAR

Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.

Intervention Type DRUG

Other Intervention Names

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Bydureon Bydureon

Eligibility Criteria

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Inclusion Criteria

* Has type 2 diabetes treated with either: \*A stable regimen of metformin for a minimum of 3 months, and/or \*Diet modification and exercise for a minimum of 3 months.
* Has HbA1c of 7.1% to 11.0%, inclusive.
* Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

Exclusion Criteria

* Received any investigational drug within 3 months prior to screening.
* Is currently treated with any of the following excluded medications: \*Thiazolidinediones within 3 months of screening; \* Sulfonylureas within 3 months of screening; \* Insulin within 1 year of screening.
* Participated previously in an exenatide clinical study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No