AWARD-CHN3

CompletedPhase 3Results posted

A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes

A Randomized, Double-Blind Trial Comparing the Effect of the Addition of Dulaglutide 1.5 mg Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Patients With Type 2 Diabetes

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

291

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 19-35•HbA1c 7-11%

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 IDNCT04591626

Org study ID17731

Secondary IDH9X-MC-GBGOEli Lilly and Company

Timeline

Milestones

Study first posted2020-10-19actual

Study start2020-12-07actual

Primary completion2022-04-28actual

Study completion2022-04-28actual

Last update posted2023-05-24actual

Results first posted2023-05-24actual

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

•are men or nonpregnant women aged ≥18 years at screening

•have been treated with basal insulin glargine once daily and metformin and/or acarbose for at least 3 months prior to screening

•doses of once daily insulin glargine and OAMs must be stable during the 3-month period prior to screening. Insulin glargine dose is considered stable when all doses during this period are within the range defined by ±20% of the most commonly used insulin glargine dose during this same period. Doses of metformin and/or acarbose are considered stable when doses are unchanged during the same period, and the doses should be in the inclusive range of the half maximum to maximum approved daily dose per the locally-approved label

•have an HbA1c value ≥7.0% and ≤11.0% as assessed by the central laboratory at screening

•require further insulin glargine dose increase at baseline per the TTT algorithm based on the SMBG data (FBG ≥5.6mmol/L) collected during the prior week

•have stable weight (±5%) ≥3 months prior to screening

•have body mass index (BMI) between ≥19.0 and ≤35.0 kg/m2 at screening

Exclusion criteria

•have type 1 diabetes (T1D)

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

•have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening

•have had any of the following CV conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke)

•have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone or plan to have a gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility

•have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening

•for participants on metformin or metformin and acarbose, have renal disease or renal dysfunction (eGFR [CKD-EPI] <45 mL/min/1.73 m2), as determined by the central laboratory; for participants on acarbose, have renal disease or renal dysfunction (eGFR [CKD-EPI] <25 mL/min/1.73 m2), as determined by the central laboratory

•have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) syndrome in the absence of known C-cell hyperplasia (the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B syndrome have a known RET mutation and the potential participant for the study is negative for the RET mutation)

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

•have serum calcitonin ≥20 pg/mL at screening, as determined by the central laboratory

•have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease)

•have been treated with any other antihyperglycemia regimen, other than basal insulin glargine once daily and metformin and/or acarbose, within the 3 months prior to screening or between screening and baseline

Endpoints (18)

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 28

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
1.5 mg Dulaglutide	-0.76	—
Placebo	0.42	—

LS Mean Difference-1.1895% CI-1.77 – -0.60p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 28

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

16 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
1.5 mg Dulaglutide	-2.03	—
Placebo	-1.08	—

LS Mean Difference-0.9595% CI-1.14 – -0.77p<0.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Achieving HbA1c <7.0%

Time frame:Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
1.5 mg Dulaglutide	75.9	—
Placebo	33.8	—

Odds Ratio (OR)10.9195% CI5.35 – 22.28p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
1.5 mg Dulaglutide	-58.47	—
Placebo	-43.64	—

LS Mean Difference-14.8295% CI-20.57 – -9.08p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

Time frame:Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
1.5 mg Dulaglutide	51.8	—
Placebo	21.1	—

Odds Ratio (OR)4.5895% CI2.64 – 7.95p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

Time frame:Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
1.5 mg Dulaglutide	74.8	—
Placebo	33.3	—

Odds Ratio (OR)7.5995% CI4.27 – 13.48p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)

Time frame:Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
1.5 mg Dulaglutide	51.8	—
Placebo	21.1	—

Odds Ratio (OR)4.5895% CI2.64 – 7.95p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile

Time frame:Baseline, Week 28

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
1.5 mg Dulaglutide	-64.0	—
Placebo	-37.7	—

LS Mean Difference-26.395% CI-33.0 – -19.6p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Daily Mean Insulin Glargine Doses

Time frame:Baseline, Week 28

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), International Units per day(IU/day)	95% CI
1.5 mg Dulaglutide	10.0	—
Placebo	14.0	—

LS Mean Difference-4.095% CI-6.86 – -1.14p0.006Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0%

Time frame:Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

Time frame:Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

Time frame:Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)

Time frame:Week 28

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile

Time frame:Baseline, Week 28

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Daily Mean Insulin Glargine Doses

Time frame:Baseline, Week 28

change from baseline, improvement

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

Effect of baseline characteristics on the efficacy of dulaglutide added to basal insulin in Chinese patients with type 2 diabetes: A subgroup analysis of AWARD-CHN3.
Diabetes, obesity & metabolism2024 Apr (month)PMID38185739doi:10.1111/dom.15416via pubmed acronym asset candidate
Efficacy and safety of adding once-weekly dulaglutide to basal insulin for inadequately controlled type 2 diabetes in Chinese patients (AWARD-CHN3): A randomized, double-blind, placebo-controlled, phase III trial.
Diabetes, obesity & metabolism2023 Dec (month)PMID37732487doi:10.1111/dom.15263via pubmed acronym asset candidate

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.