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

To evaluate the safety and efficacy of insulin Aspart-Mix biosimilar candidate GP40081 (GP-Asp30) compared with NovoMix 30 (NN-Asp30). 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.

Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid Penfill) in Type 1 diabetes mellitus.

To compare safety and efficacy of GP40071 insulin aspart (GP-Asp) and NovoRapid (NN-Asp). This randomized open-label, active-controlled, 26-week non-inferiority Phase III clinical trial enrolled 264 Type 1 diabetes mellitus patients (HbA1c: 7.1-12.