987-P: Efficacy and Safety Comparison between U-100 Human Regular Insulin and Rapid-Acting Insulin When Delivered by V-Go Wearable Insulin Delivery in an Older Type 2 Diabetes Population

Abstract

The price of insulin has risen substantially and been associated with higher out-of-pocket costs and quicker entry into the Medicare coverage gap, negatively impacting diabetes care in older adults. Evidence from a large health plan supports Human Regular Insulin (HRI), when used effectively, as a viable treatment option for many patients with T2D including older adults. In a recently completed multi-site, 14-week randomized, parallel, study (N=113), non-inferiority was demonstrated when switching from Rapid Acting Insulin (RAI) to HRI delivered by V-Go with a mean change ETD in A1C of -0.22% (95% CI -0.67, 0.22); p=0.007 favoring HRI and no statistical differences in insulin dose, weight or hypoglycemia. We explored these outcomes using mixed-effects models in a post-hoc analysis in pts ≥ 65 years of age. The intent to treat population consisted of 53 pts randomized to continue therapy with RAI (n=25) or switch to HRI (n=28). Non-inferiority for change in A1C between groups was demonstrated in this population. Insulin dose and hypoglycemia events were similar between groups. No severe hypoglycemia or moderate or severe adverse events were reported in either group. Similar to the overall study findings, use of HRI delivered by V-Go is an effective insulin therapy option in an older population and may decrease financial burdens. Disclosure D.R. Sutton: Employee; Spouse/Partner; Valeritas, Inc. Speaker’s Bureau; Self; Amarin Corporation, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Valeritas, Inc. P.F. Mora: Speaker’s Bureau; Self; Dexcom, Inc., Insulet Corporation, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US, Valeritas, Inc. A. Gore: Advisory Panel; Spouse/Partner; Janssen Pharmaceuticals, Inc. Consultant; Spouse/Partner; Janssen Pharmaceuticals, Inc. Consultant; Self; Novo Nordisk Inc. Speaker’s Bureau; Spouse/Partner; Janssen Pharmaceuticals, Inc. Speaker’s Bureau; Self; Janssen Pharmaceuticals, Inc., Merck & Co., Inc. B. Baliga: Speaker’s Bureau; Self; Amarin Corporation, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Senseonics, Valeritas, Inc. R.F. Goldfaden: None. C.C. Nikkel: Employee; Self; Valeritas, Inc. Stock/Shareholder; Self; Valeritas, Inc. J.H. Sink: Employee; Self; Valeritas, Inc. B.A. Adams-Huet: Consultant; Self; Valeritas, Inc. Funding Valeritas, Inc.