1. The efficacy and safety of GP40081 (insulin aspart biphasic 30) compared with NovoMix ® 30 in Type 2 diabetes patients.
- Author
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Drai RV, Mayorov AY, Karonova TL, Parfenova TM, Makarenko IE, Magruk MA, Alpenidze DN, Kovalik VV, Zinnatulina BR, Grigorjeva IV, and Andreeva AT
- Subjects
- Humans, Biphasic Insulins, Blood Glucose, Glycated Hemoglobin, Insulin therapeutic use, Insulin, Isophane, Biosimilar Pharmaceuticals therapeutic use, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use, Insulin Aspart therapeutic use
- Abstract
Aim: To evaluate the safety and efficacy of insulin Aspart-Mix biosimilar candidate GP40081 (GP-Asp30) compared with NovoMix
® 30 (NN-Asp30). Materials & methods: In a randomized open-label, active-controlled, 26-week non-inferiority clinical trial 264 patients with Type 2 diabetes mellitus were randomized 1:1 to receive once-daily GP-Asp30 or NN-Asp30. The primary safety end point was the immune response rate. Efficacy outcomes were a mean change in HbA1c (primary), frequency of achieving a glycemic g fasting plasma glucose levels, 7-point glucose profiles, and insulin doses. Results: The immune response developed in 10/126 (8%) participants in the GP-Asp30 group and in 10/125 (8%) participants in the NN-Asp30 group (p = 1.000). The mean difference in HbA1c change between groups was 0.12 (95%CI [-0.14, 0.38]). Other secondary efficacy and safety outcomes weren't statistically different between the two groups. Conclusion: GP-Asp30 demonstrated similar safety and efficacy compared with NN-Asp30 and may be considered a biosimilar insulin.- Published
- 2022
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