Phase 3 · Dulaglutide

AWARD-PEDS trial results

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.

Participants
154
Status
completed
Completed
2022-01-12
Sponsor
Eli Lilly and Company

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.

Primary outcome

What AWARD-PEDS measured first

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26percentage of HbA1C · Baseline, Week 26 · least squares mean
Placebon=45Pooled Dulaglutiden=100
0.5(0.24)-0.7(0.16)
Side effects by arm

Side effects in AWARD-PEDS

Percent of participants affected, Up To 56 Weeks. The most common events the registry lists.

EventPlacebo: Double-Blind Period0.75 mg Dulaglutide: Double-Blind Period1.5 mg Dulaglutide: Double-Blind PeriodPlacebo/0.75 mg Dulaglutide: Open Label Extension (OLE)0.75 mg Dulaglutide: OLE1.5 mg Dulaglutide: OLE
Any serious event5.9%2%1.9%0%2%4%
Diarrhoea13.7%15.7%21.2%0%2%12%
Vomiting3.9%17.6%13.5%8.5%8.2%10%
Nausea7.8%13.7%15.4%2.1%6.1%12%
Headache9.8%13.7%15.4%4.3%10.2%10%
Upper respiratory tract infection7.8%3.9%11.5%6.4%0%2%
Abdominal pain upper7.8%5.9%9.6%4.3%0%10%
Nasopharyngitis5.9%9.8%3.8%8.5%2%6%
Dysmenorrhoea2.4%2.9%5.9%0%0%8.8%
Gastroenteritis3.9%2%5.8%8.5%0%6%
Abdominal pain5.9%7.8%1.9%0%6.1%6%
Dizziness2%7.8%3.8%2.1%2%2%
Epistaxis2%0%0%6.4%0%0%
Pyrexia3.9%3.9%3.8%4.3%6.1%2%
Urinary tract infection5.9%3.9%0%4.3%2%0%
Accidental overdose0%5.9%3.8%0%0%0%
Heavy menstrual bleeding0%0%5.9%0%0%0%
Secondary outcomes

What else it measured

Change From Baseline in HbA1c (Individual Doses) at Week 26percentage of HbA1c · Baseline, Week 26 · least squares mean
Placebon=450.75 mg Dulaglutiden=501.5 mg Dulaglutiden=50
0.5(0.24)-0.5(0.22)-1.0(0.22)
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26millimoles per liter (mmol/L) · Baseline, Week 26 · least squares mean
Placebon=430.75 mg Dulaglutiden=491.5 mg Dulaglutiden=50Pooled Dulaglutiden=99
0.96(0.45)-0.47(0.41)-1.54(0.41)-1.03(0.29)
Percentage of Participants With HbA1c ≤7.0%percentage of participants · Week 26 · number
Placebon=450.75 mg Dulaglutiden=501.5 mg Dulaglutiden=50Pooled Dulaglutiden=100
18.4260.0053.1956.52
Change From Baseline in Body Mass Index (BMI) at Week 26kilograms/square meter (kg/m^2) · Baseline, Week 26 · least squares mean
Placebon=500.75 mg Dulaglutiden=511.5 mg Dulaglutiden=52Pooled Dulaglutiden=103
-0.0(0.21)-0.2(0.20)-0.1(0.19)-0.1(0.14)
Percentage of Participants With Self-Reported Events of Hypoglycemiapercentage of participants · Week 26 · number
Placebon=510.75 mg Dulaglutiden=511.5 mg Dulaglutiden=52
1.963.923.85
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemiapercentage of participants · Week 26 · number
Placebon=510.75 mg Dulaglutiden=511.5 mg Dulaglutiden=52Pooled Dulaglutiden=103
17.63.91.92.9
Number of Participants With Adjudicated Pancreatitisparticipants · Week 26 · number
Placebon=510.75 mg Dulaglutiden=511.5 mg Dulaglutiden=52Pooled Dulaglutiden=103
0000
Change From Baseline in Pancreatic Enzymes at Week 26Units/Liter (U/L) · Baseline, Week 26 · mean
MeasurePlacebon=470.75 mg Dulaglutiden=511.5 mg Dulaglutiden=52Pooled Dulaglutiden=103
Serum Amylase0.09(17.36)4.80(9.39)6.50(8.91)5.64(9.15)
Serum Amylase, Pancreatic0.60(9.94)1.77(4.72)2.90(6.10)2.32(5.45)
Serum Lipase2.23(31.99)4.37(8.28)3.88(6.63)4.12(7.47)
Number of Participants With Thyroid Treatment-Emergent Adverse EventsParticipants · Week 26 · count of participants
Placebon=510.75 mg Dulaglutiden=511.5 mg Dulaglutiden=52Pooled Dulaglutiden=103
0000
Change From Baseline in Serum Calcitonin at Week 26nanograms per liter (ng/L) · Baseline, Week 26 · mean
Placebon=470.75 mg Dulaglutiden=481.5 mg Dulaglutiden=48Pooled Dulaglutiden=96
0.38(1.70)0.28(0.72)0.10(0.50)0.19(0.62)
Percentage of Participants With Allergic, Hypersensitivity Reactionspercentage of participants · Week 26 · number
Placebon=510.75 mg Dulaglutiden=511.5 mg Dulaglutiden=52Pooled Dulaglutiden=103
2.03.91.92.9
Percentage of Participants With Injection Site Reactionspercentage of participants · Week 26 · number
Placebon=510.75 mg Dulaglutiden=511.5 mg Dulaglutiden=52Pooled Dulaglutiden=103
9.89.87.78.7
The trial

How AWARD-PEDS was run

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.

  • 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).
  • 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.
  • 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.
Who could join the trial

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.

Published papers

Papers from AWARD-PEDS

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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