5 results
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
To demonstrate non-inferiority of Toujeo versus *standard of care* basal insulin therapy asmeasured by HbA1c change from baseline to Month 6.
The primary objective of this study is to evaluate overall survival (OS) in the intent-to-treat (ITT) subject population defined by this protocol.Key secondary objectives are to evaluate OS in the epidermal growth factor receptor (EGFR) wild type…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
To demonstrate the noninferiority of insulin glargine 300 U/mLin comparison to insulin degludec 100 U/mL on glycemiccontrol and variability in participants with diabetes mellitus