Evaluating dulaglutide dosing in children with Type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of different doses of dulaglutide, a medication for managing Type 2 diabetes, in pediatric participants. The trial will involve children who are already being treated with diet, exercise, and stable doses of metformin or basal insulin. Participants will be monitored over an 8-month period to evaluate the safety and efficacy of the treatment. The goal is to identify optimal dosing options for this age group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening.
* Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile

Exclusion Criteria:

* Have Type 1 diabetes
* Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening
* After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
* Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
* Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease
* Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• Arkansas Childrens Hospital
  Little Rock, Arkansas, United States Recruiting
• Division of Endocrinology, Diabetes, and Metabolism
  Los Angeles, California, United States Recruiting
• UCLA Mattel Children's Hospital
  Los Angeles, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Yale Diabetes Research
  New Haven, Connecticut, United States Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.