VIVID is the first prospective, randomized controlled trial to assess efficacy and safety of U-500R (Humulin® R U-500) administered by CSII (using an investigational Omnipod U-500™ Insulin Management System) vs. MDI (TID). This 26-week, open-label, multicenter, parallel study (NCT02561078) enrolled adults with T2D on 201-600 units of insulin/day with or without other antihyperglycemic agents. We report data for the primary population (N=340), excluding participants on concomitant GLP-1 RAs or SGLT2 inhibitors. Data for the all-randomized population are reported separately. Baseline characteristics were similar between arms. CSII showed noninferior A1C reduction vs. MDI (primary objective) and superior FPG reduction at 26 weeks with adjustment for multiplicity. CSII showed significantly greater A1C reduction at a lower total daily dose with no multiplicity adjustment. Clinically important hypoglycemia rates (<54 mg/dL) and weight gain were similar; severe and nocturnal (≤70 mg/dL) hypoglycemia rates were statistically higher for CSII vs. MDI (Table). In this population, U-500R via CSII had greater efficacy at a lower dose vs. MDI with higher hypoglycemia rates for some categories. CSII with U-500R may be a viable option for T2D patients on high-dose insulin. Individualized dose titration will be important to safely achieve A1C targets.


G. Grunberger: Research Support; Self; Medtronic MiniMed, Inc., Novo Nordisk Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Janssen Pharmaceuticals, Inc.. A. Bhargava: None. T.T. Ly: Employee; Self; Insulet Corporation. H. Zisser: Employee; Self; Verily Life Sciences LLC.. Stock/Shareholder; Self; Verily Life Sciences LLC. L. Ilag: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J.K. Malone: Employee; Self; Eli Lilly and Company. S. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. J. Johnson: Employee; Self; Eli Lilly and Company.

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