Similar Safety, Efficacy, Immunogenicity Shown for Admelog and Reference Humalog

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:

• Change in HbA1c from baseline to week 26 was similar in both treatment groups, as calculated by least square (LS) mean (standard error) change in HbA1c (Admelog, —0.92% [0.051]; Humalog, –0.85% [0.051]).
• The mean decrease in HbA1c from baseline occurred mostly during the first 12 weeks of treatment.
• Noninferiority at the prespecified 0.3% noninferiority margin was demonstrated (LS mean difference of Admelog versus Humalog, —0.07% [95% CI, –0.215-0.067). Similar changes in FPG, 7-point SMPG profiles, including postprandial glucose excursions and mean glucose over 24 hours, and insulin dosages were observed in the 2 groups.
• Hypoglycemia, TAEAs, and AIA incidence and prevalence did not differ between groups. The percentage of patients with at least 1 hypoglycemia event reported at any time of the day was similar in the Admelog (68.4%) and Humalog (74.6%) groups, and similar percentages of patients reported nocturnal hypoglycemia in the Admelog group and the Humalog group. The researchers note that the occurrence of severe hypoglycemia was very low in both treatment groups.
• A similar percentage of patients in the Admelog and Humalog groups reported a TEAE (Admelog, 46.6%; Humalog, 42.9%). Serious TEAEs were reported in a lower percentage of patients in the Admelog group (5.5%) than in the Humalog group (10.7%).
• Similar percentages of patients in both treatment groups were positive for AIA at baseline. The percentage of patients with a treatment-emergent AIA response was 18.8% in the Admelog group and 14.5% in the Humalog group.
• Over the 6-month treatment period, percentages of patients positive for AIA increased slightly in both treatment groups. Similar percentages of patients in the Admelog group (38.4%) and Humalog group (36.7%) were positive for AIAs at least at 1 time point between baseline and month 6.
• A low number of patients reported hypersensitivity reactions, and very few patients reported injection-site reactions. Most events were mild or moderate in intensity; nearly all resolved while treatment was ongoing.

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.