Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

NCT00943917 · Completed

Last updated 2026-05-28

This clinical trial tested a long-acting version of the diabetes drug exenatide (ITCA 650) in adults with type 2 diabetes to see how it affects their blood sugar levels over time.

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, open-label (no blinding) treatment study

Participants 155 people

Who can join Ages 18–70 · all sexes

Timeline Started 2009-08 · est. completion 2011-02

Where 50 sites · United States

What this study is testing ClinicalTrials.gov NCT00943917 ↗

Description as written by the study sponsor.

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

Treatments tested

ITCA 650 Other

ITCA 650 (continuous delivery of exenatide in DUROS)
Exenatide Injection also known as Byetta Drug

twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
Ex Inj/ITCA 650 also known as Byetta Other

twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650

Main thing measured	Mean Change in HbA1c (Per Protocol)
Sponsor	Intarcia Therapeutics
Conditions studied	Type 2 Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00943917 ↗