Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients
brief summary
The goal of this clinical trial is to demonstrate the non-inferior immunogenicity of GP40321 compared to Apidra® SoloStar® at a concentration of 100 U/mL in type 1 diabetes mellitus patients. The main questions it aims to answer are: * What is the immunogenicity of GP40321 and Apidra® SoloStar®? * What are the efficacy and safety of GP40321 and Apidra® SoloStar®? Researchers will compare the immunogenicity, efficacy and safety parameters of GP40321 and Apidra® SoloStar®. Participants will: • Visit the clinic 9 times: once for screening, 3 times during dose titration (plus 2 telephone contacts) and 5 times during the stable dose treatment period.
official title
Multicenter, Open-Label, Randomized, Controlled Study of Non-Inferior Immunogenicity of GP40321 (Solution for Subcutaneous Injection, 100 U/mL; GEROPHARM LLC, Russia) and Apidra® SoloStar® (Solution for Subcutaneous Injection, 100 U/mL; Sanofi-Aventis Deutschland GmbH, Germany) in Type 1 Diabetes Mellitus Patients