A Phase 1, randomized, 1-day 5-period crossover study in adults with type 1 diabetes on CSII investigated whether pain is dependent on the site and/or depth of infusion of ultra rapid lispro (URLi) excipients.
Forty participants (mean age 40.5 years; BMI 27.5) were randomized to 1 of 5 infusion site sequences consisting of the abdomen, arm, thigh, and buttock (6 mm cannula depth) , and abdomen (9 mm depth) . Basal infusion of sodium citrate, treprostinil, and magnesium chloride in diluent was initiated (1 U/h) and 15 unit-equivalent boluses were given at 3, 6, and 9 h after basal initiation. Participants rated local infusion site pain perception by the 0-100 mm validated visual analog scale (VAS) at 5 min before bolus and 1 and 15 min post bolus.
An increased VAS score was occasionally reported at 1 min post bolus, more frequently for the arm. Most scores were ≤10 mm (little to no discomfort) while 7 of 577 were >45 mm (generally considered clinically meaningful pain) . VAS score distributions were similar between cannula depths (Figure) . After 15 min, scores were similar to pre bolus. No participants discontinued the study.
Local infusion site discomfort after infusion of URLi excipients was reported by a subset of participants; it was transient, tolerable, and dependent on infusion site. Given differences among sites within individuals, patients may consider changing infusion site if they experience discomfort.
D. A. Ignaut: None. T. Fukuda: Employee; Eli Lilly and Company. B. Ramanjineyulu: None. M. Ermer: None. M. S. Stoffel: None. E. Zijlstra: Speaker’s Bureau; Gan & Lee Pharmaceuticals, Novo Nordisk. D. Paavola: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company.
Eli Lilly and Company