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Abstract
URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion. This phase 3, 26-week trial evaluated the efficacy and safety of URLi vs. lispro in 1222 adults with T1D. The primary endpoint was A1C change from baseline after 26 weeks of treatment, with multiplicity adjusted objectives for PPG excursions (PPGE) after test meal. After an 8-week lead-in to optimize basal insulin glargine or degludec, patients were randomized to double-blind URLi (n=451) or lispro (n=442) given at the start of the meal, or open-label URLi (n=329) given 20 minutes after the meal (URLi +20). A1C was reduced for URLi and lispro and non-inferiority (NI) was shown: estimated treatment difference (ETD) -0.08 [-0.16; 0.00] p=0.06 (Figure). NI for URLi +20 vs. lispro was also shown: ETD +0.13 [0.04; 0.22] p=0.003. URLi was superior to lispro in controlling 1- and 2-h PPGE during the test meal (Figure). No significant differences were seen between URLi vs. lispro in rate or incidence of severe hypoglycemia; overall daily or postprandial hypoglycemia (<54 mg/dL) ≤4 h after meals, but URLi had a 37% lower hypoglycemia rate in the period >4 h, (p=0.013). Overall, the incidence of treatment-emergent adverse events was similar between groups. URLi was efficacious with a similar safety profile to lispro and, when given at start of the meal, provided superior PPG control vs. lispro. Disclosure L.J. Klaff: Research Support; Self; Abbott, Ascensia Diabetes Care, Cnoga Medical, Gan & Lee Pharmaceuticals, Lilly Diabetes, Medtronic MiniMed, Inc., Novo Nordisk Inc., REMD Biotherapeutics, Sanofi, Senseonics, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. D. Cao: Employee; Self; Eli Lilly and Company. M.A. Dellva: Employee; Self; Eli Lilly and Company. J. Tobian: Employee; Self; Eli Lilly and Company. J. Miura: None. D. Dahl: None. J.M. Bue-Valleskey: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company
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