Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

NCT00103935 · Completed

Last updated 2026-05-28

This clinical trial tested the safety, tolerability, and how the body processes exenatide long-acting release (given as a weekly injection) in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 45 people

Who can join Ages 18–75 · all sexes

Timeline Started 2005-02 · est. completion 2005-10

Where 7 sites · United States

What this study is testing ClinicalTrials.gov NCT00103935 ↗

Description as written by the study sponsor.

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.

Treatments tested

placebo 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
placebo 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
Exenatide LAR also known as Bydureon Drug

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

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

Main thing measured	Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM)
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00103935 ↗