Under My Skin: Can We Optimize Diabetes Adherence?

What would you say if I told you about a device you can implant subcutaneously in the abdomen that can deliver six months to a year’s worth of exenatide (Byetta)? And what’s more, it’s about the size of a matchstick.  Would you laugh, and say, “That sounds so far off in the future!” or, “I don’t believe it!”?

The implantable ITCA 650 (Intarcia) may be available as early as 2017. Water from the extracellular fluid enters the device, then by diffusing through a semi-permeable membrane and into a salt osmotic engine that expands to drive a piston, the drug releases at the other end.¹

This month, I touch on the Phase 3 trials for this device, and some of the potential implications of having this tool in our diabetes treatment armamentarium. The FREEDOM-1 clinical trial, presented at the 2015 American Diabetes Association Scientific Sessions, examined 460 patients who were randomized to daily exenatide doses of 40 mcg or 60 mcg versus placebo. Baseline HbA1c was between 7.5 to 10%. Both study medication groups began exenatide at 20 mcg for the first 13 weeks, then were titrated to the higher dose for 26 weeks.

At 39 weeks, average A1C reductions compared with placebo were 1.1% for those in the 40 mcg dose group, and 1.2% for the 60 mcg dose cohort.  FREEDOM-2 demonstrated an A1c reduction of 1.5% for those treated with the 60 mcg dose, compared with a 0.8% decrease in those on sitagliptin 100 mg. The latest news, just reported on May 6, 2016, is that the cardiovascular safety study of 4,000 patients (FREEDOM-CVO) met its primary and secondary endpoints. Data will be presented at an upcoming conference, according to Intarcia’s website.

[[{"type":"media","view_mode":"media_crop","fid":"48661","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_8997430226578","media_crop_h":"182","media_crop_image_style":"-1","media_crop_instance":"5835","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"187","media_crop_x":"82","media_crop_y":"8","style":"width: 250px; height: 243px; float: right;","title":"© Intarcia Therapeutics, Inc. ","typeof":"foaf:Image"}}]]One of the advantages that leaps to mind with this delivery system is 100% adherence to medication. For diabetes medications, health economists have remarked that 80% adherence is a “good” level. Unanswered questions abound - such as, how acceptable will this be to patients? While all of this is intriguing and promising, we need to await real-world experience.

What are your thoughts?

1. Intarcia Platform Technology. http://www.intarcia.com/pipeline-technology/. Accessed on May 8, 2016.