AWARD-PEDS

CompletedPhase 3Results posted

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

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)

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

154

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•HbA1c 6.5-11%•Age 10-17

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02963766

Org study ID14171

Secondary ID2016-000361-22

Secondary IDH9X-MC-GBGCEli Lilly and Company

Timeline

Milestones

Study first posted2016-11-15estimated

Study start2016-12-29actual

Primary completion2021-06-12actual

Study completion2022-01-12actual

Last update posted2022-07-01actual

Results first posted2022-07-01actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Mass Index (BMI) at Week 26

Time frame:Baseline, Week 26

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms/square meter (kg/m^2)	95% CI
Placebo	-0.0	—
0.75 mg Dulaglutide	-0.2	—
1.5 mg Dulaglutide	-0.1	—
Pooled Dulaglutide	-0.1	—

LS Mean difference (Final Values)-0.195% CI-0.7 – 0.5p0.689Mixed Models Analysis

LS Mean difference (Final Values)-0.095% CI-0.6 – 0.5p0.924Mixed Models Analysis

LS Mean difference (Final Values)-0.195% CI-0.6 – 0.4p0.776Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) at Week 26

Time frame:Baseline, Week 26

BMI, change

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1C	95% CI
Placebo	0.5	—
Pooled Dulaglutide	-0.7	—

LS Mean difference (Final Values)-1.395% CI-1.8 – -0.7p<0.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in HbA1c (Individual Doses) at Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Placebo	0.5	—
0.75 mg Dulaglutide	-0.5	—
1.5 mg Dulaglutide	-1.0	—

LS Mean difference (Final Values)-1.095% CI-1.7 – -0.4p0.002Mixed Models Analysis

LS Mean difference (Final Values)-1.595% CI-2.2 – -0.9p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Fasting Blood Glucose (FBG) at Week 26

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), millimoles per liter (mmol/L)	95% CI
Placebo	0.96	—
0.75 mg Dulaglutide	-0.47	—
1.5 mg Dulaglutide	-1.54	—
Pooled Dulaglutide	-1.03	—

LS Mean difference (Final Values)-1.4495% CI-2.65 – -0.22p0.021Mixed Models Analysis

LS Mean difference (Final Values)-2.5195% CI-3.72 – -1.29p<0.001Mixed Models Analysis

LS Mean difference (Final Values)-1.9795% CI-3.03 – -0.91p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants With HbA1c ≤7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	18.42	—
0.75 mg Dulaglutide	60.00	—
1.5 mg Dulaglutide	53.19	—
Pooled Dulaglutide	56.52	—

Odds Ratio (OR)11.03895% CI3.491 – 34.902p<0.001Regression, Logistic

Odds Ratio (OR)11.66695% CI3.653 – 37.253p<0.001Regression, Logistic

Odds Ratio (OR)11.34895% CI4.163 – 30.932p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia

Time frame:Week 26

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	17.6	—
0.75 mg Dulaglutide	3.9	—
1.5 mg Dulaglutide	1.9	—
Pooled Dulaglutide	2.9	—

Secondary/protocol endpoint

Change From Baseline in HbA1c (Individual Doses) at Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose (FBG) at Week 26

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants With HbA1c ≤7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia

Time frame:Week 26

threshold achievement, improvement

Safety / tolerability / PK

20 endpoints

Secondary/registry result

Percentage of Participants With Self-Reported Events of Hypoglycemia

Time frame:Week 26

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	1.96	—
0.75 mg Dulaglutide	3.92	—
1.5 mg Dulaglutide	3.85	—

Secondary/registry result

Number of Participants With Adjudicated Pancreatitis

Time frame:Week 26

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
Placebo	0	—
0.75 mg Dulaglutide	0	—
1.5 mg Dulaglutide	0	—
Pooled Dulaglutide	0	—

Secondary/registry result

Change From Baseline in Pancreatic Enzymes at Week 26

Time frame:Baseline, Week 26

change from baseline, descriptive

Posted result

Group	Value (mean), Units/Liter (U/L)	95% CI
PlaceboSerum Amylase	0.09	—
Serum Amylase, Pancreatic	0.60	—
Serum Lipase	2.23	—
0.75 mg DulaglutideSerum Amylase	4.80	—
Serum Amylase, Pancreatic	1.77	—
Serum Lipase	4.37	—
1.5 mg DulaglutideSerum Amylase	6.50	—
Serum Amylase, Pancreatic	2.90	—
Serum Lipase	3.88	—
Pooled DulaglutideSerum Amylase	5.64	—
Serum Amylase, Pancreatic	2.32	—
Serum Lipase	4.12	—

Secondary/registry result

Number of Participants With Thyroid Treatment-Emergent Adverse Events

Time frame:Week 26

Thyroid event

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	0	—
0.75 mg Dulaglutide	0	—
1.5 mg Dulaglutide	0	—
Pooled Dulaglutide	0	—

Secondary/registry result

Change From Baseline in Serum Calcitonin at Week 26

Time frame:Baseline, Week 26

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), nanograms per liter (ng/L)	95% CI
Placebo	0.38	—
0.75 mg Dulaglutide	0.28	—
1.5 mg Dulaglutide	0.10	—
Pooled Dulaglutide	0.19	—

Secondary/registry result

Percentage of Participants With Allergic, Hypersensitivity Reactions

Time frame:Week 26

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	2.0	—
0.75 mg Dulaglutide	3.9	—
1.5 mg Dulaglutide	1.9	—
Pooled Dulaglutide	2.9	—

Secondary/registry result

Percentage of Participants With Injection Site Reactions

Time frame:Week 26

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	9.8	—
0.75 mg Dulaglutide	9.8	—
1.5 mg Dulaglutide	7.7	—
Pooled Dulaglutide	8.7	—

Secondary/registry result

Number of Participants With Anti-Dulaglutide Antibodies

Time frame:Baseline through Week 56

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
Placebo/0.75 mg Dulaglutide	3	—
0.75 mg Dulaglutide	3	—
1.5 mg Dulaglutide	3	—

Secondary/registry result

Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)

Time frame:Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit

Cmax

concentration, descriptive

Posted result

Group	Value (mean), nanograms per milliliter (ng/mL)	95% CI
0.75 mg Dulaglutide	31	28.4 – 33.5
1.5 mg Dulaglutide	62	56.9 – 67.2

Secondary/registry result

PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanogramhour per milliliter (ngh/ mL)	95% CI
0.75 mg Dulaglutide	4170	3770 – 4510
1.5 mg Dulaglutide	8350	7640 – 9070

Secondary/protocol endpoint

Percentage of Participants With Self-Reported Events of Hypoglycemia

Time frame:Week 26

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Adjudicated Pancreatitis

Time frame:Week 26

Pancreatitis

event count, event

Secondary/protocol endpoint

Change From Baseline in Pancreatic Enzymes at Week 26

Time frame:Baseline, Week 26

change from baseline, descriptive

Secondary/protocol endpoint

Number of Participants With Thyroid Treatment-Emergent Adverse Events

Time frame:Week 26

Thyroid event

event count, event

Secondary/protocol endpoint

Change From Baseline in Serum Calcitonin at Week 26

Time frame:Baseline, Week 26

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Percentage of Participants With Allergic, Hypersensitivity Reactions

Time frame:Week 26

threshold achievement, event

Secondary/protocol endpoint

Percentage of Participants With Injection Site Reactions

Time frame:Week 26

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Anti-Dulaglutide Antibodies

Time frame:Baseline through Week 56

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)

Cmax

concentration, descriptive

Secondary/protocol endpoint

PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]

AUC₀–∞

concentration, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes.
The New England journal of medicine2022 Aug 4PMID35658022doi:10.1056/NEJMoa2204601via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.