A Look Back on Diabetes in 2015 to Look Forward in 2016 Alan B Cortez MD May 14 2016 Pediatric Endocrinology Kaiser Permanente Orange County Categories of Review rather than Preview Research Education ID: 764172
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A Look Back on Diabetes in 2015 to Look Forward in 2016 Alan B Cortez, MD May 14, 2016 Pediatric Endocrinology Kaiser Permanente Orange County
Categories of Review rather than Preview (Research) Education Nutrition Medicine Devices Software/Apps Awareness Sharing
Medicine Ultra Slow Long Acting Insulins 10+ billion dollar market Lantus to go generic soon Ultra Fast Inhaled Insulin is back Sales not brisk and the loss of Al Mann looms big SGLT2 inhibitors (all the agliflozins ) and DKA DPP- 4 inhibitors (except alogliptin ) and Heart Failure DPP-4 inhibitors and severe joint pain New Cholesterol Meds- 71% LDL reduction possible with PCSK9 inhibitors evolocumab and alirocumab and may bypass statin resistance.
Insulin Glargine ( Toujeo ) Toujeo - U300 with special pen for safety ( Sanofi and the FDA remembered mistakes of the pre-1970 insulin era) Studies in the low to mid A1c 8% range- non-inferior improvement compared to Lantus 450 units in a pen but only ½ the liquid Less hypoglycemia for most and less weight gain (by 2 pounds over 6 months) Demonstrated a good FDA process in the EDITION1-4 studies T2DM- basal and bolus insulin T2DM- basal insulin plus OADs T2DM- naïve to insulin (didn’t show hypo reduction) T1DM- (didn’t show hypo reduction) Similar price per unit but may need 12% more units
Insulin Degludec ( Tresiba ) 42 hour duration of action Comes in Pens only- U100 (300 units) and U200 (600 units) Pens Also comes as Ryzodeg - 70/30 with aspart and may soon be combined with liraglutide Approved for 8 weeks use per Pen (under 86 deg ) BEGIN studies compared it to glargine In Type 1, 25% less nocturnal hypoglycemia and similar a1c reduction. For various categories of type 2, non-inferior Safety concern with use of TZDs.
Pharmacokinetics of Insulin Degludec
Afrezza (insulin human) Smaller and more flexible to dose Unmatched prandial insulin profile compared to the nondiabetic state Should not be used in children, COPD, asthma Caution with smoking, other higher risk of lung cancer, use of TZDs Mannkind’s marketing partner , Sanofi , has discontinued their relationship but Mannkind says they will keep the product available and now is able to move forward again.
SGLT2 inhibitors and DKA 100 cases in 500,000 patient years of use Too small to be seen in initial FDA studies but to large to ignore its significance . DKA May be “ euglycemic ” Urinary glucose loss of 50-100 grams per day leads to low glucose availability in a background of low insulin availability and may lead to enhanced fat oxidation Use in unrecognized type 1 and off-label use in type 1 may also be factors
Devices FDA changes approval process of secondary display platforms on devices and the cloud Apple, Google, IBM, Samsung are now Diabetes companies too. More Pump features – integration of sensor data, more touch screen, larger reservoirs Better Sensors Loss of Asante Snap Pump- purely business reasons
Apps Universal Device Uploader Tidepool (Blip) and Glooko partnering with non-profits and for-profits. Enhanced patient access to data and data analysis Providers need to develop new revenue generating mechanisms to deal with extra time burden placed on them. More industry intercommunication More web based platforms for providers Glycemic index apps more prevalaent
Awareness Miss Idaho 2015 wears an insulin pump and is using her celebrity to promote awareness. Was just in OC for a big fund raiser last week along with 3 Miss Americas including Miss America 1999 who also won with wearing an insulin pump. Reegan’s Rule (N Carolina and now other states on the way including California)- encourages primary care providers to provide information on diabetes at well child visits. Issue has raised awareness of DKA in toddlers who have a much higher risk of death form unrecognized diabetes and DKA, as well as the difficulty in preventing it.
Education and Nutrition Has the largest bang for the buck of any intervention but sadly never much in the big picture to report in the Year in Review . Feinman et al, Nutrition Vol 31, Issue 1, Jan 2015, 1-13 is a good review as well as presenting arguments to set the bar lower for carbohydrate intake
Sharing Please share something you have been doing in the last year that you think others in the room will want to know about.