Introduction: We compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (70% intermediate SAR341402 protamine and 30% rapid SAR341402 solution) (SAR-Mix) with its originator NovoMix 30 insulin aspart mix (NN-Mix) in adults with type 1 or type 2 diabetes switching from different premix insulin analogs.
Methods: This phase 3, randomized, open-label, multinational, 26-week trial (GEMELLI M) enrolled 402 participants with type 1 or type 2 diabetes. At randomization, participants switched from their prestudy premix insulin NovoMix 30 (n = 341) or Humalog Mix 25/Liprolog Mix 25 (n = 61) to equivalent (1:1) doses of either SAR-Mix or NN-Mix at least twice daily (1:1 randomization). In this subgroup analysis, efficacy measures [change in hemoglobin A1c (HbA1c), daily insulin dose], and safety outcomes [hypoglycemia incidence, adverse events (including hypersensitivity and injection site reactions), anti-insulin aspart antibodies] of SAR-Mix were compared with those of NN-Mix separately according to the participants' prestudy premix insulin.
Results: At week 26, change from baseline in HbA1c (primary efficacy endpoint) was similar between SAR-Mix and NN-Mix in those participants pretreated with NovoMix 30 [least squares (LS) mean difference 0.05%, 95% confidence interval (CI) -0.195% to 0.289%] or Humalog Mix 25/Liprolog Mix 25 (LS mean difference 0.28%, 95% CI -0.279% to 0.830%) (P value for treatment-by-subgroup interaction = 0.46). In both subgroups, safety outcomes, including immunogenicity, and changes in daily insulin doses were similar between treatments over 26 weeks.
Conclusions: Efficacy, safety, and immunogenicity profiles of SAR-Mix are similar to NN-Mix over 26 weeks in adults with diabetes irrespective of prior type of premix insulin.
Trial Registration: EudraCT number 2017-000092-84.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9159382 | PMC |
| http://dx.doi.org/10.1007/s13300-022-01279-z | DOI Listing |
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