The efficacy and safety of GP40081 (insulin aspart biphasic 30) compared with NovoMix® 30 in Type 2 diabetes patients

J Comp Eff Res. 2022 Dec;11(18):1337-1347. doi: 10.2217/cer-2021-0232. Epub 2022 Dec 13.

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.

Keywords: GP-Asp30; biosimilar; endocrinology/metabolism; immunogenicity; insulin aspart; phase III study.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biosimilar Pharmaceuticals* / therapeutic use
  • Biphasic Insulins
  • Blood Glucose
  • Diabetes Mellitus, Type 2* / drug therapy
  • Glycated Hemoglobin
  • Humans
  • Hypoglycemic Agents* / therapeutic use
  • Insulin / therapeutic use
  • Insulin Aspart* / therapeutic use
  • Insulin, Isophane

Substances

  • Biosimilar Pharmaceuticals
  • Biphasic Insulins
  • Blood Glucose
  • Glycated Hemoglobin
  • Hypoglycemic Agents
  • Insulin
  • Insulin Aspart
  • Insulin, Isophane
  • insulin aspart, insulin aspart protamine drug combination 30:70