A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood … (NCT07160816) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar
Germany, Italy245 participantsStarted 2025-08-28
Plain-language summary
The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 1 diabetes (T1D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 30 weeks.
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:
* Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available insulin icodec has been made by the participant/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
* Male or female, age greater than or equal to (≥) 18 years at the time of signing informed consent.
* Diagnosed with T1D ≥ 1 year before signing informed consent.
* Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before signing informed consent.
* Available HbA1c value less than or equal to (≤) 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice.
* Treatment naïve to once-weekly insulin prior to the 'Initiation Visit' (V1).
Exclusion Criteria:
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Treatment with any investigational drug within 30 days prior to enrolment into the study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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.
1Since this study is actively enrolling but no longer recruiting new participants, is there any chance I could still be considered, or are there similar insulin icodec studies I might qualify for instead?
2Insulin icodec is described as a once-weekly basal insulin — how does dosing once a week compare to the daily long-acting insulin I might already be using, and what does my doctor think that change could mean for my specific Type 1 diabetes management?
3The main thing this study is measuring is change in HbA1c, but what other aspects of blood sugar control should I be asking about, like time-in-range or hypoglycemia risk, that this trial may not be tracking as a primary goal?
4Since this trial doesn't list a phase, what does that tell us about how much is already known regarding the safety and effectiveness of insulin icodec in people with Type 1 diabetes specifically?
5Given that I have Type 1 diabetes, where insulin management is especially complex, would my doctor consider standard treatment options a safer or more predictable path right now compared to participating in a study like this one?
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.