ITCA 650 provides a novel therapeutic approach to treating patients with type 2 diabetes (T2D)
AAPA ePoster library. Whitson A. 05/17/17; 180511; 137
Amy Whitson
Amy Whitson
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Abstract
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Background and aims: ITCA 650 is a novel delivery system and glucagon-like peptide-1 (GLP-1) receptor agonist that can provide continuous subcutaneous (SC) exenatide for up to 12 months after sub-dermal placement of a small, 44 mm titanium osmotic mini-pump. Three and 6-month mini-pumps were studied in clinical trials of 39 weeks or more that showed significant reductions in HbA1c and body weight, and were well tolerated in patients with T2D who were uncontrolled on anti-diabetes medications. This novel drug/device can ensure maintenance of therapeutic exenatide levels and virtually ensures treatment adherence. We present the procedure experience from the FREEDOM Phase 3 program. Materials and methods: Placement and removal of ITCA 650 is performed by trained healthcare professionals as a simple brief office procedure. The sterile mini-pump is placed in the sub-dermis of the abdominal wall using a placement tool, is removed or replaced through a small incision (~5 mm) and closed with Steri-Strips. Site personnel are provided with a kit containing all supplies and are trained on all procedures via an online and hands-on training program. Results: As of November 2015, over 18,383 ITCA 650 placements, replacements, and removals were performed in 5,200 patients by physicians, nurse practitioners, and physician assistants at 493 clinical sites in 28 countries. Procedure adverse events (AEs) were generally mild, transient, and reflect the normal healing process. Superficial skin infection occurred in 0.4% of all procedures. Approximately 1% of procedures were initially unsuccessful and required further assistance to complete; this number that continues to decrease due to an optimized training and user experience program. Next generation placement aids will support continuous improvements. To date, only 0.19% of procedure AEs (0.7% of patients) resulted in treatment discontinuation. There were no procedure serious AEs. Conclusions: Once or twice-yearly dosing of ITCA 650 has the potential to improve therapeutic outcomes. Procedures to place, replace, and remove the mini-pumps are simple, well tolerated, and have been performed safely by a wide variety of healthcare practitioners....
Background and aims: ITCA 650 is a novel delivery system and glucagon-like peptide-1 (GLP-1) receptor agonist that can provide continuous subcutaneous (SC) exenatide for up to 12 months after sub-dermal placement of a small, 44 mm titanium osmotic mini-pump. Three and 6-month mini-pumps were studied in clinical trials of 39 weeks or more that showed significant reductions in HbA1c and body weight, and were well tolerated in patients with T2D who were uncontrolled on anti-diabetes medications. This novel drug/device can ensure maintenance of therapeutic exenatide levels and virtually ensures treatment adherence. We present the procedure experience from the FREEDOM Phase 3 program. Materials and methods: Placement and removal of ITCA 650 is performed by trained healthcare professionals as a simple brief office procedure. The sterile mini-pump is placed in the sub-dermis of the abdominal wall using a placement tool, is removed or replaced through a small incision (~5 mm) and closed with Steri-Strips. Site personnel are provided with a kit containing all supplies and are trained on all procedures via an online and hands-on training program. Results: As of November 2015, over 18,383 ITCA 650 placements, replacements, and removals were performed in 5,200 patients by physicians, nurse practitioners, and physician assistants at 493 clinical sites in 28 countries. Procedure adverse events (AEs) were generally mild, transient, and reflect the normal healing process. Superficial skin infection occurred in 0.4% of all procedures. Approximately 1% of procedures were initially unsuccessful and required further assistance to complete; this number that continues to decrease due to an optimized training and user experience program. Next generation placement aids will support continuous improvements. To date, only 0.19% of procedure AEs (0.7% of patients) resulted in treatment discontinuation. There were no procedure serious AEs. Conclusions: Once or twice-yearly dosing of ITCA 650 has the potential to improve therapeutic outcomes. Procedures to place, replace, and remove the mini-pumps are simple, well tolerated, and have been performed safely by a wide variety of healthcare practitioners....
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