A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Purpose
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.
Condition
- Type 2 Diabetes
Eligibility
- Eligible Ages
- Between 10 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Placebo/0.75 milligram (mg) Dulaglutide |
Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE). |
|
|
Experimental 0.75 mg Dulaglutide |
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE. |
|
|
Experimental 1.5 mg Dulaglutide |
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE. |
|
Recruiting Locations
More Details
- NCT ID
- NCT02963766
- Status
- Completed
- Sponsor
- Eli Lilly and Company