A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

Key facts

Study ID

NCT02963766

Run by

Eli Lilly and Company

People needed

154

Starts

2016-12-29

Expected to finish

2022-01-12

Last updated by the study team

2022-07-01

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening.
• Have HbA1c >6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5 % to ≤9%.
• Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).

You may not qualify if…

• Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.
• A history of, or at risk for pancreatitis.
• Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening.
• A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg.
• Active or treated cancer.
• A blood disorder where an accurate HbA1c may not be obtainable.
• A female of childbearing age, sexually active and not on birth control.
• Pregnant or plan to be pregnant during the study, or breastfeeding.
• Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).
• Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.
• Using prescription weight loss medications in the last 30 days, or plan to use.
• Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Advanced Research Center — Anaheim, California, United States
• Division of Endocrinology, Diabetes, and Metabolism — Los Angeles, California, United States
• Childrens Hospital of Orange County — Orange, California, United States
• Center of Excellence in Diabetes & Endocrinology — Sacramento, California, United States
• Rady Childrens Hospital - San Diego — San Diego, California, United States
• JC Cabaccan — San Jose, California, United States
• Touro University — Vallejo, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Florida Center for Endocrinology & Metabolism — Orlando, Florida, United States
• St. Luke's Regional Medical Center — Boise, Idaho, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• ECU Pediatric Specialty Care — Greenville, North Carolina, United States
• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Childrens Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Seattle Children's Hospital Research Foundation — Seattle, Washington, United States
• Multicare Health System — Tacoma, Washington, United States
• CAMC Institute — Charleston, West Virginia, United States
• Instituto Estadual de Diabetes e Endocrinologia — Rio de Janeiro, Rio de Janeiro, Brazil
• Centro de Pesquisas em Diabetes — Porto Alegre, Rio Grande do Sul, Brazil
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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