Overview

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

Status:
COMPLETED

Trial end date:
2023-11-28

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

Geropharm

Treatments:

Insulin Glargine
insulin glulisine