Phase 3
Completed N=154
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Type 2 Diabetes
Source: ClinicalTrials.gov NCT02963766 ↗
Enrolled (actual)
154
Serious AEs
2.7%
Results posted
Jul 2022
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 — 0.5; -0.7 percentage of HbA1C — p=<0.001
◆ Published Evidence
Highly cited
139citations · ~35 / year
Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes.
Summary
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.
Linked Publications (2)
-
Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes.
-
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 |
0.5; -0.7 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c (Individual Doses) at Week 26 |
0.5; -0.5; -1.0 | 0.002 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) at Week 26 |
0.96; -0.47; -1.54; -1.03 | 0.021 sig |
| SECONDARY Percentage of Participants With HbA1c ≤7.0% |
18.42; 60.00; 53.19; 56.52 | <0.001 sig |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at Week 26 |
-0.0; -0.2; -0.1; -0.1 | 0.689 |
| SECONDARY Percentage of Participants With Self-Reported Events of Hypoglycemia |
1.96; 3.92; 3.85 | — |
| SECONDARY Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia |
17.6; 3.9; 1.9; 2.9 | — |
| SECONDARY Number of Participants With Adjudicated Pancreatitis |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Pancreatic Enzymes at Week 26 |
0.09; 4.80; 6.50; 5.64; 0.60; 1.77 | — |
| SECONDARY Number of Participants With Thyroid Treatment-Emergent Adverse Events |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Serum Calcitonin at Week 26 |
0.38; 0.28; 0.10; 0.19 | — |
| SECONDARY Percentage of Participants With Allergic, Hypersensitivity Reactions |
2.0; 3.9; 1.9; 2.9 | — |
| SECONDARY Percentage of Participants With Injection Site Reactions |
9.8; 9.8; 7.7; 8.7 | — |
| SECONDARY Number of Participants With Anti-Dulaglutide Antibodies |
3; 3; 3 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss) |
31; 62 | — |
| SECONDARY PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss] |
4170; 8350 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02963766) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.