1005-P: Comparison of Hypoglycemia Safety between U-100 Human Regular Insulin and Rapid-Acting Insulin Delivered By V-Go Wearable Insulin Delivery in Type 2 Diabetes

Hypoglycemia was evaluated in a 14-week multi-center randomized, parallel, non-inferiority study comparing the efficacy and safety of Rapid Acting Insulin (RAI) versus Human Regular Insulin (HRI) when delivered by V-Go. Glucose lowering agents were to remain stable unless hypoglycemia warranted removal and down-titration of insulin was recommended if glucose levels were consistently lower than target range. Patients were instructed to self-monitor blood glucose (SMBG) daily and perform 7-point SMBG profiles within 3 days of each study visit. Hypoglycemia was defined as: Level 1: ≤70 mg/dl; Level 2: ≤54 mg/dl; and Level 3: severe cognitive impairment requiring external assistance for recovery. The intent to treat population (ITT) consisted of 136 patients randomized to continue treatment with RAI (n=67) or switch to HRI (n=69). Percentages of hypoglycaemia events were similar between groups when comparing pre to post-randomization and the between group difference was not significant. Post-randomization hypoglycemic event rate/person week decreased in both groups compared to pre-randomization. No level 3 events were reported in either group. The incident rate ratio (IRR) was not significant at any level. This study demonstrates the risk of hypoglycemia is not increased when using HRI compared to RAI in V-Go in a T2D population. Disclosure P.F. Mora: Speaker’s Bureau; Self; Dexcom, Inc., Insulet Corporation, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US, Valeritas, Inc. 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. 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.