A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
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.
- Type 2 Diabetes
- Eligible Ages
- Between 10 Years and 17 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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).
- Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis after taking diabetes medication.
- 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 ≥100mmHg.
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
Dose 1 Dulaglutide
|Dulaglutide given subcutaneously (SC).||
Dose 2 Dulaglutide
|Dulaglutide given SC.||
|Placebo given SC.||
- NCT ID
- Eli Lilly and Company