Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin

Autor:	Bhaswati Mukherjee, Suzanne Pierre, Edward Franek, Viral N. Shah, Karita Sadeharju, Karin Wernicke-Panten
Rok vydání:	2021
Předmět:	medicine.medical_specialty Endocrinology Diabetes and Metabolism medicine.medical_treatment 030209 endocrinology & metabolism Subgroup analysis Type 2 diabetes GEMELLI 1 030204 cardiovascular system & hematology Hypoglycemia Subgroup by prior mealtime insulin Insulin aspart 03 medical and health sciences 0302 clinical medicine Internal medicine Diabetes mellitus Internal Medicine medicine Biosimilar insulin Original Research Insulin glargine business.industry Insulin SAR341402 medicine.disease Basal (medicine) business medicine.drug
Zdroj:	Diabetes Therapy
ISSN:	1869-6961 1869-6953
Popis:	Introduction The biosimilar SAR341402 insulin aspart (SAR-Asp) was compared to its originator NovoLog®/NovoRapid® insulin aspart (NN-Asp) in terms of efficacy, safety, and immunogenicity, in adults with type 1 or type 2 diabetes switching from different rapid-acting insulin analogs. Methods This phase 3, randomized, open-label, multinational, 52-week study (GEMELLI 1) enrolled participants with type 1 or type 2 diabetes (n = 597). At randomization, participants transitioned from NovoLog/NovoRapid (n = 380) or Humalog®/Liprolog® (n = 217) to equivalent (1:1) doses (or a dose at the discretion of the investigator) of either SAR-Asp or NN-Asp (1:1 randomization). Participants were treated with multiple daily injections in combination with insulin glargine 100 U/mL (Lantus®). In this subgroup analysis, efficacy measures (change in hemoglobin A1c [HbA1c], insulin dose [total, basal and mealtime]), and safety outcomes (hypoglycemia incidence, adverse events, anti-insulin aspart antibodies) of SAR-Asp were compared with those of NN-Asp separately according to the participants’ prestudy mealtime insulin. Results At week 26 (primary efficacy endpoint), change in HbA1c was similar between SAR-Asp and NN-Asp in those participants pre-treated with NovoLog/NovoRapid (least squares [LS] mean difference − 0.04%, 95% confidence interval [CI] − 0.182 to 0.106%) or Humalog/Liprolog (LS mean difference − 0.15%, 95% CI − 0.336 to 0.043%) (P value for treatment by subgroup interaction = 0.36). This HbA1c response persisted over the 52 weeks of the study similarly for both treatments within each subgroup. In both subgroups, changes in insulin doses were similar between treatments over 26 weeks and 52 weeks, as were the incidences of severe or any hypoglycemia, adverse events (including hypersensitivity and injection site reactions), and anti-insulin aspart antibodies. Conclusions Efficacy and safety (including immunogenicity) profiles of SAR-Asp are similar to those of NN-Asp over 52 weeks in adults with diabetes irrespective of prior type of mealtime insulin. Trial Registration ClinicalTrials.gov identifier: NCT03211858. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-020-00992-x.
Databáze:	OpenAIRE
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