Long Term, Injection Free Treatment with ITCA 650, Continuous Subcutaneous Delivery of Exenatide via DUROS Device Leads to Sustained Improved Glycaemi

Long Term, Injection Free Treatment with ITCA 650, Continuous Subcutaneous Delivery of Exenatide via DUROS Device Leads to Sustained Improved Glycaemic Control and Weight Loss for 48 Weeks in Metformin Treated Type 2 Diabetes
Julio Rosenstock
ADA 2011.


The DUROS is an implantable device that gives a continuous infusion of exenatide. The present study is a 48 weeks extension of a previously reported (EASD 2010) shorter clinical trial.
The ITCA was implanted every 3 months and is an osmotic mini pump shaped like a rod. A salt tablet at one end absorbs water through a semi permeable membrane at one end of the titanium rod from the subcutaneous tissue and as it swells it causes a piston to move and thus infuse the drug from a chamber beyond the piston. The rod is about 2.5cm long.
The proof of concept study was presented at EASD 2010. There were ITCA 2 doses tested in that trial (20mcg and 40mcg) which were then increased in a randomized way to 20-80 mcg of exenatide daily. The comparator group was exenatide bd subcutaneous injections
Compared to baseline, at 24 weeks there was a sustained but not greater than in the original study reduction in HbA1c of 0.9% in those staying on 20mcg. In those moving from 20-60mcg daily the HbA1 there was a 1.4% reduction in HbA1c thus there was an additional benefit with the higher dose. There was the same initial frequency of nausea in the ITCA and exenatide injection groups but the ICTA group ended up with significantly less nausea as the rates fell whereas they stayed unchanged in the S/C exenatide injection group.
At the end of the 24 week extension patients were offered the chance to sstay involved in an extension trial although this was a non-randomised stage. The HbA1c reduction remained constant out to 48 weeks. Body weight changed from 12-24 weeks while the doses of ITCA infused exenatide were increased. However in the 24-48 week period there was no further reduction in weight, which remained constant.
The data form this series of studies suggest that in phase 3 studies the preferred doe if ITCA infused exenatide should be 60mcg daily as this achieves the best combination of HbA1c and weight reductions.