Evaluating Health Status in the PRONTO-Pump-2 Study

Background: In PRONTO-Pump-2, a Phase 3, 16-week, randomized, double-blind clinical trial in patients with type 1 diabetes on continuous subcutaneous insulin infusion, ultra rapid lispro (URLi) showed superior postprandial glucose control and noninferior HbA1c reduction, with less hypoglycemia compared to Humalog® (Lispro). Although primarily reported as mild in severity, incidence of infusion site reactions was higher with URLi compared to Humalog (37.7% vs. 10.1%). We assessed patient-reported health status in the PRONTO-Pump-2 trial as an exploratory measure. Methods: The EQ-5D-5L (which includes a visual analogue scale rating perceived health [VAS; 0-100 from worst to best imaginable health state]) was administered at baseline and endpoint (week 16 or early discontinuation) to patients on URLi (N=215) or Humalog (N=217). The EQ-5D-5L assesses 5 dimensions of health status (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) for which a health state index score ranging from less than 0 (worse than death) to 1 (perfect health) is calculated. Change from baseline to endpoint (last observation carried forward) in scores was analyzed using an ANCOVA model. Results: At endpoint, mean health state index scores showed no significant differences between treatments (URLi, 0.88 [standard error 0.009]; Humalog, 0.89 [0.009]) with an increase from baseline of +0.01 (0.009) within each treatment. On the dimension of pain/discomfort, distribution of responses was similar between treatments. Endpoint VAS scores were also similar between URLi and Humalog (80.2 [0.82] and 80.8 [0.78], respectively) but decreased from baseline within each treatment: URLi, -1.1 (0.82); Humalog -0.5 (0.78). Conclusion: In PRONTO-Pump-2, the EQ-5D-5L indicated no differences in health status, including the pain/discomfort dimension, between patients on URLi versus Humalog, despite more frequent reports of infusion site reactions with URLi treatment. Disclosure R. Paczkowski: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Amgen Inc., Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Amgen Inc. C. Piras de oliveira: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. J. Cho: None. A. Goldyn: Employee; Self; Eli Lilly and Company. J. Poon: Employee; Self; Eli Lilly and Company. E. R. Hankosky: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. D. A. Ignaut: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company