AWARD-11

CompletedPhase 3Results posted

A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

208

Recruiting sites

—

Enrollment

1,842

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7.5-11%

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 IDNCT03495102

Org study ID16877

Secondary ID2017-003490-33

Secondary IDH9X-MC-GBGLEli Lilly and Company

Timeline

Milestones

Study start2018-04-05actual

Study first posted2018-04-11actual

Primary completion2019-05-28actual

Study completion2019-10-10actual

Last update posted2020-06-12actual

Results first posted2020-06-12actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have type 2 diabetes mellitus (T2DM) for at least 6 months

•Have been treated with stable metformin dose for at least 3 months

•Have HbA1c ≥7.5% and ≤11.0% at study entry

•Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m^2)

Exclusion criteria

•Have type 1 diabetes mellitus

•Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)

•Have been taking any other medicine for diabetes (other than metformin) during the last 3 months

•Have used in the last 3 months (or plan to use) prescription weight loss medications

•Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss

•Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)

•Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial

•Had chronic or acute pancreatitis any time prior to study entry

•Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity

•Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in

•Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2

•Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator

Endpoints (14)

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

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight From Baseline

Time frame:Baseline, Week 36

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilograms (Kg)	95% CI
Dulaglutide 1.5 mg	-3.1	—
Dulaglutide 3 mg	-4.0	—
Dulaglutide 4.5 mg	-4.7	—

Mean Difference (Net)-0.995% CI-1.4 – -0.4p0.001Mixed Models Analysis

Mean Difference (Net)-1.695% CI-2.1 – -1.1p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change in Body Weight From Baseline

Time frame:Baseline, Week 36

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Change in Hemoglobin A1c (HbA1c) From Baseline

Time frame:Baseline, Week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Dulaglutide 1.5 mg	-1.53	—
Dulaglutide 3 mg	-1.71	—
Dulaglutide 4.5 mg	-1.87	—

Mean Difference (Net)-0.1795% CI-0.29 – -0.06p0.003Mixed Models Analysis

Mean Difference (Net)-0.3495% CI-0.45 – -0.22p<0.001Mixed Models Analysis

Primary/protocol endpoint

Change in Hemoglobin A1c (HbA1c) From Baseline

Time frame:Baseline, Week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Achieving HbA1c Target <7.0%

Time frame:Week 36

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Dulaglutide 1.5 mg	56.98	—
Dulaglutide 3 mg	64.68	—
Dulaglutide 4.5 mg	71.48	—

Odds Ratio (OR)1.4995% CI1.12 – 1.98p0.006Regression, Logistic

Odds Ratio (OR)2.2395% CI1.65 – 3.01p<0.001Regression, Logistic

Secondary/registry result

Change in Fasting Serum Glucose (FSG) From Baseline

Time frame:Baseline, Week 36

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
Dulaglutide 1.5 mg	-44.2	—
Dulaglutide 3 mg	-47.9	—
Dulaglutide 4.5 mg	-52.3	—

Mean Difference (Net)-3.795% CI-7.8 – 0.5p0.084Mixed Models Analysis

Mean Difference (Net)-8.195% CI-12.3 – -3.9p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Target <7.0%

Time frame:Week 36

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Serum Glucose (FSG) From Baseline

Time frame:Baseline, Week 36

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Rate of Documented Symptomatic Hypoglycemic Episodes

Time frame:Week 36

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), Episodes/participant/365.25 days	95% CI
Dulaglutide 1.5 mg	0.02	—
Dulaglutide 3 mg	0.00	—
Dulaglutide 4.5 mg	0.02	—

Secondary/registry result

Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)

Time frame:Week 4, Week 12, Week 36, Week 52

Cmax

concentration, descriptive

Posted result

Group	Value (mean), nanogram/milliliter (ng/mL)	95% CI
Dulaglutide 1.5 mg	79.6	77.7 – 81.7
Dulaglutide 3 mg	159	155 – 163
Dulaglutide 4.5 mg	238	232 – 243

Secondary/registry result

Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State

Time frame:Week 4, Week 12, Week 36, Week 52

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanogramhour/milliliter (ngh/mL)	95% CI
Dulaglutide 1.5 mg	11200	10900 – 11500
Dulaglutide 3 mg	22300	21800 – 22900
Dulaglutide 4.5 mg	33400	32700 – 34200

Secondary/protocol endpoint

Rate of Documented Symptomatic Hypoglycemic Episodes

Time frame:Week 36

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)

Time frame:Week 4, Week 12, Week 36, Week 52

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State

Time frame:Week 4, Week 12, Week 36, Week 52

AUC₀–∞

concentration, descriptive

Publications (3)

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

Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes.
Cardiovascular diabetology2023 Mar 9PMID36894938doi:10.1186/s12933-023-01775-xvia clinicaltrials gov reference derived + pubmed nct search
Effect of expanded dulaglutide weekly doses (3.0 mg and 4.5 mg) on cardiovascular disease risk factors in participants with type 2 diabetes at increased cardiovascular disease risk: a post hoc analysis of the AWARD-11 study.
Diabetes, obesity & metabolism2022 Sep (month)PMID35546790doi:10.1111/dom.14762via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11).
Diabetes care2021 Mar (month)PMID33397768doi:10.2337/dc20-1473via 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.