AWARD-JPN

CompletedPhase 3Results posted

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

591

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≥18.5

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 IDNCT04809220

Org study ID17779

Secondary IDH9X-JE-GBGQEli Lilly and Company

Timeline

Milestones

Study first posted2021-03-22actual

Study start2021-04-13actual

Primary completion2022-10-01actual

Study completion2023-04-26actual

Results first posted2023-09-21actual

Last update posted2024-05-22actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.

•Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.

•Have the following HbA1c result at screening.

–Participants taking DPP-4i: ≥7.5% and ≤9.5%,

–Participants taking another OAM: ≥8.0% and ≤10.0%

•Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks

•Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and <35 kg/m² at Day 1.

Exclusion criteria

•Have type 1 diabetes (T1D)

•Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma

•Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)

•Have a known clinically significant gastric empty abnormality

•Have acute or chronic hepatitis

•Have had chronic or acute pancreatitis

•Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia

•Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)

•Have evidence of significant, active autoimmune abnormality

•Have evidence of significant, uncontrolled endocrine abnormality

•Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years

•Have any hematologic condition that may interfere with HbA1c measurement

Endpoints (12)

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

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
Dulaglutide 1.5 mg	-0.5	—
Dulaglutide 0.75 mg	-0.2	—

LS Mean Difference-0.395% CI-0.8 – 0.2p0.213Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c) 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
Dulaglutide 1.5 mg	-1.53	—
Dulaglutide 0.75 mg	-1.25	—

LS Mean Difference-0.2995% CI-0.43 – -0.14p<.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c) 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 at Week 52

Time frame:Baseline, Week 52

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	-1.50	—
Dulaglutide 0.75 mg	-1.19	—

LS Mean Difference-0.3195% CI-0.47 – -0.15p<.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Dulaglutide 1.5 mgHbA1c ≤ 6.5%	22.88	—
HbA1c < 7%	46.33	—
Dulaglutide 0.75 mgHbA1c ≤ 6.5%	21.26	—
HbA1c < 7%	38.51	—

Odds Ratio (OR)1.1595% CI0.71 – 1.87p0.560Generalized Linear Mixed Model (GLM)

For HbA1c ≤6.5%

Odds Ratio (OR)1.6195% CI1.05 – 2.45p0.028Generalized Linear Mixed Model (GLM)

For HbA1c \< 7%

Secondary/registry result

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 52

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	-42.4	—
Dulaglutide 0.75 mg	-33.1	—

LS Mean Difference-9.495% CI-14.4 – -4.3p<.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Dulaglutide 1.5 mgMorning premeal-fasting	-45.6	—
Morning 2-hour post meal	-70.6	—
Midday premeal	-55.3	—
Midday 2-hour post meal	-73.7	—
Evening premeal	-50.3	—
Evening 2-hour post meal	-61.1	—
Dulaglutide 0.75 mgMorning premeal-fasting	-38.4	—
Morning 2-hour post meal	-60.5	—
Midday premeal	-47.0	—
Midday 2-hour post meal	-61.2	—
Evening premeal	-46.4	—
Evening 2-hour post meal	-49.8	—

LS Mean Difference-7.295% CI-11.7 – -2.7p0.002ANCOVA

Morning premeal-fasting

LS Mean Difference-10.195% CI-18.3 – -1.9p0.016ANCOVA

Morning 2-hour post meal

LS Mean Difference-8.395% CI-14.2 – -2.3p0.007ANCOVA

Midday premeal

LS Mean Difference-12.595% CI-20.5 – -4.5p0.002ANCOVA

Midday 2-hour post meal

LS Mean Difference-3.995% CI-9.3 – 1.5p0.158ANCOVA

Evening premeal

LS Mean Difference-11.395% CI-19.0 – -3.7p0.004ANCOVA

Evening 2-hour post meal

Secondary/protocol endpoint

Change From Baseline in HbA1c at Week 52

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Publications (1)

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

A randomized, double-blind trial assessing the efficacy and safety of two doses of dulaglutide in Japanese participants with type 2 diabetes (AWARD-JPN).
Diabetes, obesity & metabolism2024 Aug (month)PMID38715179doi:10.1111/dom.15644via 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.