Mark Warren, United States of America
Physicians East EndocrinologyPresenter of 1 Presentation
IMPROVED POSTPRANDIAL GLUCOSE (PPG) CONTROL WITH ULTRA RAPID LISPRO (URLI) VERSUS LISPRO WITH CONTINUOUS SUBCUTANEOUS INSULIN INFUSION (CSII) IN TYPE 1 DIABETES (T1D)
Abstract
Background and Aims
URLi is a novel insulin lispro formulation developed to more closely match physiological insulin secretion. This Phase 3, 16-week, treat-to-target study evaluated efficacy and safety of URLi vs. Lispro in adults with T1D on CSII. Primary endpoint was HbA1c change from baseline.
Methods
After a 2-week lead-in on Lispro, patients were randomised to double-blind URLi (N=215) or Lispro (N=217). Two-week blinded continuous glucose monitoring (CGM) sessions were conducted prior to randomisation, and at weeks 8 and 16. Additionally, a standardised meal test was performed at randomisation and at week 16 to evaluate PPG control.
Results
Change from baseline to week 16 in HbA1c for URLi was non-inferior to Lispro: least squares mean (LSM) difference 0.3 mmol/mol (0.02%) with 95% CI of -0.6 to +1.2 mmol/mol (-0.06 to +0.11%). URLi was superior to Lispro in controlling 1- and 2-h PPG levels during the meal test (Figure). Compared to lispro, URLi resulted in significantly less percent time in hypoglycaemia (<3.0 mmol/L [54 mg/dL]) over the nighttime and 24-hour period: LSM difference -0.97% and -0.52%, respectively, both p<0.05. Time spent between 3.9-10.0 mmol/L (70-180 mg/dL) and in hyperglycaemia was similar between groups.
Incidence of treatment-emergent adverse events was higher with URLi (60.5% vs. 44.7%), primarily driven by infusion site reaction and infusion site pain. The rate and incidence of severe hypoglycaemia and diabetic ketoacidosis were similar between groups.
Conclusions
URLi was efficacious, providing superior PPG control and an acceptable safety profile compared to Lispro in patients with T1D on CSII.