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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients who develop an immune response
Timeframe: From screening to the end of treatment at Week 26
. 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);