Human Regular U-500 Insulin via Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections in Adults with T2D—The VIVID Study—All Randomized Population

VIVID is the first prospective randomized controlled trial evaluating CSII (using an investigational Omnipod U-500™ Insulin Management System) vs. MDI (TID) with U-500R (Humulin^® R U-500). This was a 26-week, open-label, multicenter, parallel study in adults with T2D on high dose insulin (201-600 units/day) with or without other antihyperglycemic agents (NCT02561078). We present results for the all randomized population (N=420); results for the primary population (excluding participants on concomitant GLP-1 RAs or SGLT2 inhibitors) are reported separately. Baseline characteristics were similar between arms. Without adjusting for multiplicity, CSII demonstrated significantly greater reduction in A1C and FPG at a lower total daily dose vs. MDI at 26 weeks. Also, a higher percentage of participants on CSII reached A1C targets <7.0%, <7.5%, and <8.0%. Severe hypoglycemia rates were low. Other hypoglycemia rates were similar (documented symptomatic) or higher (nocturnal) for CSII vs. MDI. Weight gain was similar (Table). In the all randomized population, U-500R via CSII demonstrated greater efficacy at a lower dose with a higher nocturnal hypoglycemia rate vs. MDI. CSII with U-500R may be a viable option for patients with T2D on high dose insulin. Individualized dose titration will be important for safely achieving glycemic targets.