Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients

Summary

This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that of NovoRapid®.

Timeline

Start

2019-06-03

Primary completion

2020-01-21

Completion

2020-01-21

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary safety end point was immune response at week 26. PMID 33928797 ↗

paper The groups were similar in frequency of immune response (p = 0.323) PMID 33928797 ↗

Publications

• Karonova TL, Mayorov AY, Magruk MA, Zyangirova ST, Grigoryeva IV, Khmelnitski OK, Myshkovets A, Parfenova TM, Mosikian AA, Drai RV. Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid(R) Penfill(R)) in Type 1 diabetes mellitus. J Comp Eff Res. 2021 Jun;10(9):763-775. doi: 10.2217/cer-2020-0208. Epub 2021 Apr 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin aspart	Protein / enzyme biologic	1 iu	Subcutaneous
Subject	insulin aspart	Protein / enzyme biologic	80 iu	Subcutaneous

Indications