Aim: to compare head-to-head pharmacokinetics (PK), pharmacodynamics (PD), glucose fluxes and lipid metabolism of clinical doses of insulin glargine U300 (Gla-300) and degludec U100 (IDeg) in real life in T1DM.
Methods: 22 subjects [(11M, age 44±12, T1DM for 26±12 years, BMI 22.5±3.2 kg/m2, A1C 7.1±0.6% (53.4±7.1 mmol/mol)] on Gla-100, naïve to Gla-300 and IDeg, were studied (24h euglycemic clamp) with individual doses of Gla-300 and IDeg (dosing at 20.0h) after 3 months of optimal titration of basal-bolus insulin (random crossover).
Results (at present in 14 of the 22 subjects, PD only, data in progress): preclamp A1C was similar with Gla-300 vs. IDeg. Individual basal insulin dose was greater with Gla-300 vs. IDeg (0.35±0.09 vs. 0.27±0.06 U/kg, p<0.01). Average PG (0-24h) was euglycemic on both occasions (p=NS). Area under curve of glucose infused [AUC-GIR(0-24h)] was equivalent for the two insulins (ratio 1.03, 90% C.I. 0.9, 1.22) (Figure). Within-day PD variability tended to be lower with Gla-300 vs. IDegl (CV 51% vs. 59%, p<0.051).
Conclusions. In T1DM, PD of clinical doses of Gla-300 are equivalent to IDeg with a trend for lower within-day variability.
P. Lucidi: Other Relationship; Self; Abbott, Novo Nordisk A/S. F. Porcellati: Board Member; Self; AstraZeneca, Eli Lilly and Company, Sanofi. Consultant; Self; Medtronic. P. Candeloro: None. P. Cioli: None. C. Pascucci: None. G.B. Bolli: Advisory Panel; Self; Sanofi. Research Support; Self; A. Menarini Diagnostics, Medtronic. C. Fanelli: Advisory Panel; Self; Sanofi. Other Relationship; Self; Menarini Group.