AWARD-9

CompletedPhase 3Results posted

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

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

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

300

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7-10.5%

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 IDNCT02152371

Org study ID13195

Secondary ID2012-004229-25

Secondary IDH9X-MC-GBDIEli Lilly and Company

Timeline

Milestones

Study first posted2014-06-02estimated

Results first posted2016-12-07estimated

Last update posted2019-09-25actual

Study start2014-05 (month precision)

Primary completion2015-10actual (month precision)

Study completion2015-10actual (month precision)

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 (based on the World Health Organization's [WHO] diagnostic criteria)

•Have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening

•Doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (≥1500 mg/day) and the maximum approved dose per the locally-approved label

•Have an HbA1c value ≥7.0% and ≤10.5% as assessed by the central laboratory at screening

•Require further insulin glargine dose increase at week 3 per the treat-to-target (TTT) algorithm based on the SMPG data collected during the prior week

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

•Have body mass index (BMI) ≤45 kilograms per square meter (kg/m^2) at screening

•Are able and willing to administer once weekly randomized therapy

•Are females of childbearing potential who must:

–Test negative for pregnancy at screening, based on a serum pregnancy test

–Agree to use a reliable method of birth control

–Not be breastfeeding

Exclusion criteria

•Have been treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with or without metformin, within the 3 months prior to screening or between screening and week 3

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

•Have a history of hypoglycemia unawareness within the 6 months prior to screening

•Have been treated with drugs that promote weight loss within the 3 months prior to screening or between screening and week 3

•Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks prior to screening or between screening and week 3

•Have had any of the following cardiovascular 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 or have undergone gastric bypass surgery or restrictive bariatric surgery

•Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory

•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

•Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 square meter (mL/min/m^2), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory; for participants on metformin, have renal disease or renal dysfunction (for example, a serum creatinine ≥1.5 mg/deciliter [dL] [male] or ≥1.4 mg/dL [female] or eGFR [CKD-EPI] <60 mL/min/1.73 m^2)

•Have evidence of a significant, uncontrolled endocrine abnormality

•Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) 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 MEN 2A or 2B syndrome)

•Have serum calcitonin ≥20 picograms/mL, as determined by the central laboratory

•Have evidence of a significant, active autoimmune abnormality

•Have any other condition not listed in this section that is a contraindication for use of insulin glargine, or, for participants using metformin, have a condition that is a contraindication for the use of metformin and would require metformin discontinuation per label

•Have a history of transplanted organ

•Have a history of active or untreated malignancy, or are in remission from a clinically significant malignancy during the 5 years prior to screening

•Have a history of any other condition which, in the opinion of the investigator, may preclude the participants from following and completing the protocol

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

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

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events

Time frame:Baseline through 28 Weeks

Expanded / custom MACE composite

event count, event

componentsAll-cause death, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any)

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline to 28 Weeks in Body Weight

Time frame:Baseline, 28 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram(kg)	95% CI
Dulaglutide + Insulin Glargine	-1.91	—
Placebo + Insulin Glargine	0.50	—

LS Means Difference-2.4195% CI-3.19 – -1.64p<.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to 28 Weeks in Body Weight

Time frame:Baseline, 28 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

16 endpoints

Primary/registry result

Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 28 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of change	95% CI
Dulaglutide + Insulin Glargine	-1.44	—
Placebo + Insulin Glargine	-0.67	—

LS Means Diff-0.7795% CI-0.97 – -0.56p<.001Mixed Model for Repeated Measures (MMRM)

Primary/protocol endpoint

Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 28 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)

Time frame:Baseline, 28 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligram per deciliter (mg/dL)	95% CI
Dulaglutide + Insulin Glargine	-44.63	—
Placebo + Insulin Glargine	-27.90	—

LS Mean Diff-16.7395% CI-26.02 – -7.44p<.001Mixed Models Analysis

Secondary/registry result

Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)

Time frame:Baseline, 28 Weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Dulaglutide + Insulin GlarginePre-Morning Meal (n=133,129)	-44.03	—
Morning Meal 2-Hour Postprandial (n=123,119)	-64.16	—
Pre-Midday Meal (n=133,127)	-40.89	—
Midday Meal 2-Hour Post Prandial (n=123,117)	-51.13	—
Pre-Evening Meal (n=133,129)	-43.68	—
Evening Meal 2-Hour Postprandial (n=126,122)	-48.63	—
3:00 AM (Morning) (n=124,117)	-39.77	—
Placebo + Insulin GlarginePre-Morning Meal (n=133,129)	-35.97	—
Morning Meal 2-Hour Postprandial (n=123,119)	-46.97	—
Pre-Midday Meal (n=133,127)	-25.34	—
Midday Meal 2-Hour Post Prandial (n=123,117)	-32.98	—
Pre-Evening Meal (n=133,129)	-28.71	—
Evening Meal 2-Hour Postprandial (n=126,122)	-27.35	—
3:00 AM (Morning) (n=124,117)	-20.30	—

LS Mean Diff-8.0695% CI-13.87 – -2.25p.007Mixed Models Analysis

Pre-Morning Meal

LS Mean Diff-17.1895% CI-25.96 – -8.40p<.001Mixed Models Analysis

Morning Meal 2-Hour Postprandial

LS Mean Diff-15.5595% CI-23.58 – -7.52p<.001Mixed Models Analysis

Pre-Midday Meal

LS Mean Diff-18.1595% CI-27.18 – -9.12p<.001Mixed Models Analysis

Midday Meal 2-Hour Postprandial

LS Mean Diff-14.9695% CI-23.93 – -5.99p.001Mixed Models Analysis

Pre-Evening Meal

LS Mean Diff-21.2895% CI-32.46 – -10.10p<.001Mixed Models Analysis

Evening Meal 2-Hour Postprandial

LS Mean Diff-19.4895% CI-28.77 – -10.18p<.001Mixed Models Analysis

3:00AM (Morning)

Secondary/registry result/low confidence

Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose

Time frame:Baseline, 28 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units (u)	95% CI
Dulaglutide + Insulin Glargine	12.75	—
Placebo + Insulin Glargine	25.94	—

LS Means Diff-13.1995% CI-19.55 – -6.84p<.001MMRM

Secondary/registry result

Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%

Time frame:28 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Dulaglutide + Insulin GlargineHbA1c <= 6.5	50.7	—
HbA1c < 7.0	69.3	—
Placebo + Insulin GlargineHbA1c <= 6.5	16.7	—
HbA1c < 7.0	35.3	—

Odds Ratio (OR)6.6695% CI3.70 – 12.00p<.001Regression, Logistic

Odds Ratio, log5.7195% CI3.35 – 9.73p<.001Regression, Logistic

Secondary/registry result

Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)

Time frame:28 Weeks

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
Dulaglutide + Insulin Glargine	40.7	—
Placebo + Insulin Glargine	16.7	—

Odds Ratio (OR)4.1795% CI2.32 – 7.47p<.001Regression, Logistic

Secondary/registry result

Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)

Time frame:28 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Dulaglutide + Insulin Glargine	52.0	—
Placebo + Insulin Glargine	28.0	—

Odds Ratio (OR)3.6195% CI2.09 – 6.23p<.001Regression, Logistic

Secondary/registry result

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

Time frame:28 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Dulaglutide + Insulin Glargine	52.7	—
Placebo + Insulin Glargine	20.0	—

Odds Ratio (OR)5.6095% CI3.26 – 9.62p<.001Regression, Logistic

Secondary/protocol endpoint

Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)

Time frame:Baseline, 28 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)

Time frame:Baseline, 28 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose

Time frame:Baseline, 28 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%

Time frame:28 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time frame:28 Weeks

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 Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)

Time frame:28 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:28 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

13 endpoints

Secondary/registry result

Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events

Time frame:Baseline through 28 Weeks

event count, event

componentsAll-cause death, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any)

Posted result

Group	Value (number), participants	95% CI
Dulaglutide + Insulin Glargine	3	—
Placebo + Insulin Glargine	1	—

Secondary/registry result

Percentage of Participants With Self-Reported Events of Hypoglycemia

Time frame:Baseline through 28 Weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Dulaglutide + Insulin GlargineSymptomatic	35.3	—
Asymptomatic	42.7	—
Severe	0.7	—
Nocturnal	28.0	—
Probable Symptomatic	2.7	—
Placebo + Insulin GlargineSymptomatic	30.0	—
Asymptomatic	39.3	—
Severe	0.0	—
Nocturnal	28.7	—
Probable Symptomatic	2.0	—

Secondary/registry result

Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia

Time frame:Baseline through 28 Weeks

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Dulaglutide + Insulin Glargine	0	—
Placebo + Insulin Glargine	0	—

Secondary/registry result

Number of Participants With Adjudicated Acute Pancreatitis Events

Time frame:Baseline through 28 Weeks

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
Dulaglutide + Insulin Glargine	0	—
Placebo + Insulin Glargine	0	—

Secondary/registry result

Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)

Time frame:Baseline through 28 Weeks

Thyroid event

event count, event

Posted result

Group	Value (number), participants	95% CI
Dulaglutide + Insulin Glargine	1	—
Placebo + Insulin Glargine	0	—

Secondary/registry result

Number of Participants With Dulaglutide Anti-Drug Antibodies

Time frame:Baseline, Week 12 and Week 28

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (number), participants	95% CI
Dulaglutide + Insulin Glargine	0	—
Placebo + Insulin Glargine	2	—

Secondary/registry result

Rate of Hypoglycemic Events up to 28 Weeks

Time frame:Baseline through 28 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), rate of hypoglycemic events per 30 days	95% CI
Dulaglutide + Insulin Glargine	0.63	—
Placebo + Insulin Glargine	0.70	—

Secondary/protocol endpoint

Percentage of Participants With Self-Reported Events of Hypoglycemia

Time frame:Baseline through 28 Weeks

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia

Time frame:Baseline through 28 Weeks

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Number of Participants With Adjudicated Acute Pancreatitis Events

Time frame:Baseline through 28 Weeks

Pancreatitis

event count, event

Secondary/protocol endpoint

Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)

Time frame:Baseline through 28 Weeks

Thyroid event

event count, event

Secondary/protocol endpoint

Number of Participants With Dulaglutide Anti-Drug Antibodies

Time frame:Baseline, Week 12 and Week 28

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Rate of Hypoglycemic Events up to 28 Weeks

Time frame:Baseline through 28 Weeks

Documented hypoglycemia

event count, event

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

Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration.
Diabetes, obesity & metabolism2018 Jun (month)PMID29430801doi:10.1111/dom.13252via clinicaltrials gov reference derived + pubmed nct search
Patient-reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9).
Clinical therapeutics2017 Nov (month)PMID29110972doi:10.1016/j.clinthera.2017.10.002via 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.