Abstract
Background and Aims
SAR341402 (SAR-Asp) was developed as a biosimilar/follow-on to rapid-acting insulin NovoLog®/NovoRapid® (NN-Asp). Efficacy and safety results, including immunogenicity, for SAR-Asp and NN-Asp in patients with type 1 diabetes (T1DM) or type 2 diabetes (T2DM) are similar. Further subgroups analyses were done by baseline factors (age, ethnicity, race, BMI, duration of diabetes and HbA1c).
Methods
GEMELLI-1 (NCT03211858) was a 6-month (with 6-month extension) open-label randomised phase 3 study of SAR-Asp and NN-Asp in people with T1DM or T2DM using insulin glargine 100 U/mL (Gla-100) as basal insulin. Primary endpoint was HbA1c change (non-inferiority margin of 0.3 %) from baseline to Week 26.
Results
597 participants were randomized, with similar baseline characteristics in both treatment groups. The mean change in HbA1c at Week 26 was similar in both treatment groups in the total cohort as well as in subgroup analyses based on baseline BMI (≥30 vs <30 kg/m2), duration of diabetes (≥10 or <10 years), eGFR (≥60 vs <60 mL/min/1.73 m2), and ethnicity (Table). In these subgroups, the incidence of hypoglycaemia, especially severe hypoglycaemia (SAR-Asp 4.0%; NN-Asp 3.4%), was similar in participants who received SAR-Asp and NN-Asp. The immunogenicity data and TEAEs in subgroups were also consistent with the overall population (Table).
Conclusions
SAR341402 was as effective and well tolerated as insulin aspart in people with T1DM or T2DM regardless of the baseline characteristics.
