NCT07070752

Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Geropharm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitis

Interventions

Type	Name	Description
DRUG	GP40321	GP40321, solution for subcutaneous injection, 100 U/mL (GEROPHARM LLC, Russia)
DRUG	Apidra® SoloStar®	Apidra® SoloStar®, solution for subcutaneous injection, 100 U/mL (Sanofi-Aventis Deutschland GmbH, Germany)
DRUG	RinGlar®	Patients also receive long-acting basal insulin therapy (insulin glargine 100 U/mL) throughout the study

Timeline

• Start date: 2023-04-14
• Primary completion: 2023-11-28
• Completion: 2023-11-28
• First posted: 2025-07-17
• Last updated: 2025-07-22

Locations

17 sites across 1 country: Russia