Childhood Type 2 Diabetes Study of a Single Dose of "LY3209590" a Weekly Insulin Injection
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Description
The aim of this study is to evaluate safety, and tolerability of insulin LY3209590 following a single dose given to children with type 2 diabetes mellitus (T2DM). This will be the first study to evaluate LY3209590 in pediatric patients with T2DM.
Screening:
All 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
What to expect
Study Procedures:
Prior to each study visit, participants will need to be fasting (nothing to eat or drink except water for at least 8 hours).
Screening visit:
The screening tests include blood and urine tests, medical history, a physical exam, height, weight and vital signs and an ECG.
After screening, eligible participants can continue into the treatment phase of the study.
Day 1
Dose 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.
Days 3, 5, 7, 15, 29, 43
The following procedures will take place at these visits:
- Blood collection
- Vital signs measured (day 7 only)
Day 65
- 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.
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