Childhood Type 2 Diabetes Study of a Single Dose of "LY3209590" a Weekly Insulin Injection
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Description
ScreeningAll participants will be screened up to 28 days prior to dosing.
Treatment and Assessment Period On Day 1, participants will receive a single 100-Unit subcutaneous dose of LY3209590 at the clinical research unit. Follow up research visits will be performed on Days 3, 5, 7, 15, 29, 43, and 65. Blood sampling and safety assessments will be performed at each in clinic visit. Before each study visit, subjects will need to fast for at least 8 hours.
A follow-up telephone call will be performed on approximately Day 72. The total time for participation is the study is about 100 days.
Eligibility and criteria
IRB Number:
24-021989
Eligible age range:
Clinical trial phase:
Phase I
Official title:
What to expect
Screening visitThe screening tests include blood and urine tests, medical history, a physical exam, height, weight and vital signs and an ECG.Â
After screening, eligible participants can continue into the treatment phase of the study. Â
Day 1Dose of LY3209590 will be given via injection. Blood tests will be performed and a glucose meter, test strips, diary card, and training will be provided.Â
Days 3, 5, 7, 15, 29, 43The following procedures will take place at these visits:
- Blood collection
- Vital signs measured (day 7 only)
- Weight and vital signs measured
- Blood and urine collected for laboratory tests
- Glucose meter, test strips, and diary card returned
Follow-up Phone Call Approximately 1 week after Day 65 or 2 weeks after Early Termination, participants will receive a brief follow-up phone call from the study staff.Â
Related specialties
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