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Childhood Type 2 Diabetes Study of a Single Dose of "LY3209590" a Weekly Insulin Injection

Childhood Type 2 Diabetes Study of a Single Dose of "LY3209590" a Weekly Insulin Injection

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If you are interested in participating in the study or want to learn more, please contact: Contact us
This study is now recruiting. Learn more about enrolling here.

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. 
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:
10 years - 17 years
Clinical trial phase:
Phase I
Official title:
A Single Dose Study to Evaluate the Pharmacokinetics of LY3209590 in Pediatric Participants with Type 2 Diabetes Mellitus

What to expect

Study ProceduresPrior to each study visit, participants will need to be fasting (nothing to eat or drink except water for at least 8 hours).
Screening visitThe 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 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. 
Days 3, 5, 7, 15, 29, 43The 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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Your time and participation make a difference in supporting the work of the Research Institute and children in our community. Learn more about opportunities to participate in our research.

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