1. Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid ® Penfill ® ) in Type 1 diabetes mellitus.
- Author
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Karonova TL, Mayorov AY, Magruk MA, Zyangirova ST, Grigoryeva IV, Khmelnitski OK, Myshkovets A, Parfenova TM, Mosikian AA, and Drai RV
- Subjects
- Blood Glucose, Glycated Hemoglobin, Humans, Hypoglycemic Agents therapeutic use, Insulin Aspart therapeutic use, Insulin Glargine, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 2
- Abstract
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). more...- Published
- 2021
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