A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes (NCT05262387) | Clinical Trial Compass
CompletedPhase 1
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Canada25 participantsStarted 2022-02-14
Plain-language summary
This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.
Who can participate
Age range
18 Years – 55 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:
* Male or female participants with type 1 diabetes
* Body mass index (BMI) between 18.5 and 29.0 kilograms per square meter (kg/m²), inclusive
* Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
* Using CSII and stable insulin regimen for at least 6 months prior to inclusion into the trial
* Able to undergo at least 1 hour of moderate-intensity exercise
Exclusion Criteria:
* Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
* Have a blood loss of more than 500 milliliters (mL) within the last month
* Have known allergies to insulin lispro, related compounds or any components of the study drug formulation
* Have previously participated or withdrawn from this study
* Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Participants who have an abnormal blood pressure and/or pulse rate
* Participants with clinically significant cardiac or pulmonary disease
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
Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
Timeframe: Start (0 minute) to end of exercise (60 minutes)