© 2024 MJH Life Sciences™ and Center for Biosimilars®. All rights reserved.
SAR342434, or Admelog, a follow-on of insulin lispro (Humalog), showed similar efficacy, safety, and immunogenicity to its reference in patients with type 2 diabetes who also used insulin glargine (Lantus) as basal insulin, according to the results of the SORELLA-2 study, published in the January 2018 issue of Diabetes Technology & Therapeutics.
SAR342434, or Admelog, a follow-on of insulin lispro (Humalog), showed similar efficacy, safety, and immunogenicity to its reference in patients with type 2 diabetes who also used insulin glargine (Lantus) as basal insulin, according to the results of the SORELLA-2 study, published in the January 2018 issue of Diabetes Technology & Therapeutics.
Karl-Michael Derwahl, MD, PhD, and colleagues conclude that Admelog and Humalog, when used for 6 months in combination with Lantus, provide effective and similar glucose control in patients with type 2 diabetes. Admelog is sponsored by Sanofi, which funded the study.
SORELLA-2 was a 6-month, randomized, open-label, multinational Phase 3 study in patients with diabetes who received multiple daily injections of Admelog (n = 253) or Humalog (n = 252) plus once-daily Lantus. Insulin doses were adjusted to achieve fasting and 2-hour postprandial glucose targets according to American Diabetes Association guidelines.
The study’s primary endpoint was the hemoglobin A1c (HbA1c) change from baseline to week 26; secondary endpoints included fasting plasma glucose (FPG), 7-point self-monitored plasma glucose (SMPG) profiles, hypoglycemic events, treatment emergent adverse events (TEAEs), and anti-insulin antibodies (AIA).
Researchers report the following:
The investigators note that, because the study population was largely adult white Caucasian patients with small numbers of black and Asian patients, caution should be taken when extending the results to other ethnic populations or subgroups.