Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Ty… (NCT07070752) | Clinical Trial Compass
CompletedPhase 3
Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients
Russia224 participantsStarted 2023-04-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Insulin glargine (100 U/mL)
✓. Insulin aspart (100 U/mL) OR
✓. Insulin lispro (100 U/mL) OR
✓. Insulin glulisine (100 U/mL)
Exclusion criteria
✕. Proliferative diabetic retinopathy, which may require intervention during the study period (laser ablation, surgical treatment, injectable drugs, etc.), in the opinion of the Investigator;
✕. Severe diabetic peripheral or autonomic neuropathy, in the opinion of the Investigator;
✕. Chronic kidney disease (including diabetic nephropathy) with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²;
✕. Current diabetic foot syndrome that may require intervention during the study period (surgical treatment, wound rehabilitation, limb relief, adjuvant therapy, antibacterial therapy, etc.).
✕. Episode of severe hypoglycemia (which required the help of another person or hospitalization);
What they're measuring
1
Proportion of patients who develop an immune response
Timeframe: From screening to the end of treatment at Week 26