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Clinical trial

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

NCT07070752 is registered in ClinicalTrials.gov with Geropharm as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Geropharm
Phase
Phase 3
Overall status
Completed
Start date
April 14, 2023
Completion date
November 28, 2023
Enrollment
224 (actual)
Sites
17

Conditions

As the registry lists them; a condition with its own page is linked.

type 1 diabetes mellitis