Single‐dose euglycemic clamp study in two cohorts to compare exposure of SAR341402 (insulin aspart) Mix 70/30 to US‐ and EU‐Approved versions of insulin aspart Mix 70/30 and SAR341402 rapid‐acting solution in patients with type 1 diabetes
Diabetes, Obesity and Metabolism Dec 10, 2020
Kapitza C, Nosek L, Schmider W, et al. - Given that SAR341402 Mix 70/30 (SARAsp‐Mix) is a premixed formulation with 70% protamine‐crystallized insulin aspart and 30% soluble insulin aspart, researchers conducted this randomized, double‐blind, crossover trial to compare pharmacokinetic exposure of SARAsp‐Mix to US‐ and EU‐approved versions of insulin aspart Mix 70/30 (NovoLog Mix 70/30 [NN‐Mix‐US] / NovoMix 30 [NN‐Mix‐EU]) and SAR341402 insulin aspart solution (SAR‐Asp) in patients with type 1 diabetes. For this analysis, 52 patients received a single subcutaneous 0.3 U/kg dose of each treatment and underwent a euglycemic clamp procedure lasting for a maximum of 24 h after dosing. According to findings, SARAsp‐Mix showed comparable pharmacokinetic exposure to commercially available insulin aspart Mix 70/30 formulations, and a distinct exposure profile compared with SAR‐Asp.
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