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

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.

Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure

“…Tested drugs would be investigated on diabetes mellitus populations throughout the immunogenicity investigation similarly to previously developed rapid-acting insulin biosimilars. [14][15][16] Insulin glulisine was measured by mathematical correction of total insulin, evaluated by nonspecific ELISA. Corrections were made by Owen's method used in clamp studies.…”

“…Although healthy subjects are not a target population for insulin glulisine treatment, it does not impact the biosimilarity investigation. Tested drugs would be investigated on diabetes mellitus populations throughout the immunogenicity investigation similarly to previously developed rapid‐acting insulin biosimilars 14–16 …”