A randomized, double-blind, crossover, clamp study to assess pharmacokinetics and pharmacodynamics of biosimilar Insulin Aspart (MYL-1601D) versus NovoLog and NovoRapid
Latest Information Update: 31 Dec 2021
At a glance
- Drugs Insulin aspart (Primary)
- Indications Diabetes mellitus; Type 1 diabetes mellitus
- Focus Pharmacodynamics; Pharmacokinetics
- Acronyms Euglycaemic glucose clamp study
- 01 Dec 2021 Results assessing PK and PD variables of MYL-1601D insulin aspart in comparison with Ref-InsAsp-EU and Ref-InsAsp-US, published in the Diabetes, Obesity and Metabolism.
- 09 Aug 2021 New trial record
- 29 Jun 2021 Primary endpoint has been met (PD endpoint:AUC GIR (mg/kg)1 and GIRmax (mg/kg/min)1) , according to Results presented at the 81st Annual Scientific Sessions of the American Diabetes Association