Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog ® ) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study.

Thomas C BlevinsYaron RaiterBin SunCharles DonnellyRoxann ShapiroAnoop ChullikanaAnita RaoLaxmikant VashishtaGopinath RangannaAbhijit Barve

Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (2022)

MYL-1601D demonstrated similar immunogenicity, efficacy, and safety profiles to Ref-InsAsp-US in patients with T1D over 24 weeks. CLINICAL TRIAL REGISTRATION CLINICALTRIALS.GOV: NCT03760068.

Keyphrases

clinical trial
open label
type diabetes
phase ii
glycemic control
study protocol
gestational age
phase iii
phase ii study
metabolic syndrome
double blind
radiation therapy
insulin resistance
skeletal muscle
placebo controlled