A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

2019 ◽  
Author(s):  
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Insulin Aspart ◽  
Safety And Efficacy

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

2021 ◽  
Author(s):  
Tatiana L Karonova ◽  
Alexander Y Mayorov ◽  
Maxim A Magruk ◽  
Svetlana T Zyangirova ◽  
Irina V Grigoryeva ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Immune Response ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Insulin Aspart ◽  
Phase Iii ◽  
Open Label ◽  
Safety And Efficacy ◽  
Number Of Patients

Aim: To compare safety and efficacy of GP40071 insulin aspart (GP-Asp) and NovoRapid® (NN-Asp). Materials & methods: This randomized open-label, active-controlled, 26-week non-inferiority Phase III clinical trial enrolled 264 Type 1 diabetes mellitus patients (HbA1c: 7.1–12.0%) randomized 1:1 to once daily GP-Asp (n = 132) or NN-Asp (n = 132). The primary safety end point was immune response at week 26. Results: The groups were similar in frequency of immune response (p = 0.323) and in other safety end points. Mean HbA1c change from baseline was -0.57% for GP-Asp and -0.56% for NN-Asp and did not differ between groups (p = 0.955). Intergroup mean difference of HbA1c level change (95% CI) at week 26 from baseline was 0.00 (-0.26, 0.25) %. Insulin doses, fasting plasma glucose levels and seven-point glucose profiles were similar between groups (p > 0.05). The number of patients experiencing hypoglycemic episodes did not differ between the groups (p = 0.497). Conclusion: GP-Asp demonstrated similar safety and efficacy. Trial registration number: NCT04079413 ( ClinicalTrials.gov ).

Sign in / Sign up

Export Citation Format

Share Document