Background and Aims

URLi is a novel insulin lispro formulation that shows accelerated absorption and improved postprandial glucose control compared to lispro. We evaluated the compatibility and safety of URLi vs. lispro in patients with T1D currently using CSII. Primary endpoint was the rate of infusion set failures due to a pump occlusion alarm, or unexplained hyperglycemia with blood glucose >250 mg/dL (13.9 mmol/L) that did not decrease within 1 hour following a correction bolus delivered via the pump.

Methods

This Phase 3, double-blind, crossover study included 6 weeks of each treatment after a 2-week lead-in period on lispro. Forty-nine patients were randomized. Boluses were initiated 0-2 minutes prior to meals. Patients were required to

- Change infusion sets every 72 ± 4 hours

- Record infusion set changes and reason

- Use Dexcom G5 (real-time mode)

Results

There was no significant difference in the incidence and rate of infusion set failures between URLi and Lispro (primary endpoint). URLi showed a statistically significantly higher overall premature infusion set change rate, but difference was small, translating to 1 additional infusion set change every 2-3 months.

A higher incidence of treatment-emergent adverse events (TEAEs) was observed for URLi, driven by infusion site reaction and pain, which was mostly reported by one investigative site. Over 90% of these were mild severity. Incidence of all other TEAEs was low and similar between groups.

Conclusions

URLi was compatible with CSII use with a safety profile similar to lispro. URLi demonstrated a trend towards improved glycemic control in patients with T1D.