What AWARD-PEDS measured first
| Placebon=45 | Pooled Dulaglutiden=100 |
|---|---|
| 0.5(0.24) | -0.7(0.16) |
A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 (percentage of HbA1C), Baseline, Week 26. Placebo: 0.5; Pooled Dulaglutide: -0.7.
As posted on ClinicalTrials.gov (NCT02963766), updated at source Jul 1, 2022. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Placebon=45 | Pooled Dulaglutiden=100 |
|---|---|
| 0.5(0.24) | -0.7(0.16) |
Percent of participants affected, Up To 56 Weeks. The most common events the registry lists.
| Event | Placebo: Double-Blind Period | 0.75 mg Dulaglutide: Double-Blind Period | 1.5 mg Dulaglutide: Double-Blind Period | Placebo/0.75 mg Dulaglutide: Open Label Extension (OLE) | 0.75 mg Dulaglutide: OLE | 1.5 mg Dulaglutide: OLE |
|---|---|---|---|---|---|---|
| Any serious event | 5.9% | 2% | 1.9% | 0% | 2% | 4% |
| Diarrhoea | 13.7% | 15.7% | 21.2% | 0% | 2% | 12% |
| Vomiting | 3.9% | 17.6% | 13.5% | 8.5% | 8.2% | 10% |
| Nausea | 7.8% | 13.7% | 15.4% | 2.1% | 6.1% | 12% |
| Headache | 9.8% | 13.7% | 15.4% | 4.3% | 10.2% | 10% |
| Upper respiratory tract infection | 7.8% | 3.9% | 11.5% | 6.4% | 0% | 2% |
| Abdominal pain upper | 7.8% | 5.9% | 9.6% | 4.3% | 0% | 10% |
| Nasopharyngitis | 5.9% | 9.8% | 3.8% | 8.5% | 2% | 6% |
| Dysmenorrhoea | 2.4% | 2.9% | 5.9% | 0% | 0% | 8.8% |
| Gastroenteritis | 3.9% | 2% | 5.8% | 8.5% | 0% | 6% |
| Abdominal pain | 5.9% | 7.8% | 1.9% | 0% | 6.1% | 6% |
| Dizziness | 2% | 7.8% | 3.8% | 2.1% | 2% | 2% |
| Epistaxis | 2% | 0% | 0% | 6.4% | 0% | 0% |
| Pyrexia | 3.9% | 3.9% | 3.8% | 4.3% | 6.1% | 2% |
| Urinary tract infection | 5.9% | 3.9% | 0% | 4.3% | 2% | 0% |
| Accidental overdose | 0% | 5.9% | 3.8% | 0% | 0% | 0% |
| Heavy menstrual bleeding | 0% | 0% | 5.9% | 0% | 0% | 0% |
| Placebon=45 | 0.75 mg Dulaglutiden=50 | 1.5 mg Dulaglutiden=50 |
|---|---|---|
| 0.5(0.24) | -0.5(0.22) | -1.0(0.22) |
| Placebon=43 | 0.75 mg Dulaglutiden=49 | 1.5 mg Dulaglutiden=50 | Pooled Dulaglutiden=99 |
|---|---|---|---|
| 0.96(0.45) | -0.47(0.41) | -1.54(0.41) | -1.03(0.29) |
| Placebon=45 | 0.75 mg Dulaglutiden=50 | 1.5 mg Dulaglutiden=50 | Pooled Dulaglutiden=100 |
|---|---|---|---|
| 18.42 | 60.00 | 53.19 | 56.52 |
| Placebon=50 | 0.75 mg Dulaglutiden=51 | 1.5 mg Dulaglutiden=52 | Pooled Dulaglutiden=103 |
|---|---|---|---|
| -0.0(0.21) | -0.2(0.20) | -0.1(0.19) | -0.1(0.14) |
| Placebon=51 | 0.75 mg Dulaglutiden=51 | 1.5 mg Dulaglutiden=52 |
|---|---|---|
| 1.96 | 3.92 | 3.85 |
| Placebon=51 | 0.75 mg Dulaglutiden=51 | 1.5 mg Dulaglutiden=52 | Pooled Dulaglutiden=103 |
|---|---|---|---|
| 17.6 | 3.9 | 1.9 | 2.9 |
| Placebon=51 | 0.75 mg Dulaglutiden=51 | 1.5 mg Dulaglutiden=52 | Pooled Dulaglutiden=103 |
|---|---|---|---|
| 0 | 0 | 0 | 0 |
| Measure | Placebon=47 | 0.75 mg Dulaglutiden=51 | 1.5 mg Dulaglutiden=52 | Pooled Dulaglutiden=103 |
|---|---|---|---|---|
| Serum Amylase | 0.09(17.36) | 4.80(9.39) | 6.50(8.91) | 5.64(9.15) |
| Serum Amylase, Pancreatic | 0.60(9.94) | 1.77(4.72) | 2.90(6.10) | 2.32(5.45) |
| Serum Lipase | 2.23(31.99) | 4.37(8.28) | 3.88(6.63) | 4.12(7.47) |
| Placebon=51 | 0.75 mg Dulaglutiden=51 | 1.5 mg Dulaglutiden=52 | Pooled Dulaglutiden=103 |
|---|---|---|---|
| 0 | 0 | 0 | 0 |
| Placebon=47 | 0.75 mg Dulaglutiden=48 | 1.5 mg Dulaglutiden=48 | Pooled Dulaglutiden=96 |
|---|---|---|---|
| 0.38(1.70) | 0.28(0.72) | 0.10(0.50) | 0.19(0.62) |
| Placebon=51 | 0.75 mg Dulaglutiden=51 | 1.5 mg Dulaglutiden=52 | Pooled Dulaglutiden=103 |
|---|---|---|---|
| 2.0 | 3.9 | 1.9 | 2.9 |
| Placebon=51 | 0.75 mg Dulaglutiden=51 | 1.5 mg Dulaglutiden=52 | Pooled Dulaglutiden=103 |
|---|---|---|---|
| 9.8 | 9.8 | 7.7 | 8.7 |
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.
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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.