AWARD-8

CompletedPhase 3Results posted

Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)

A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8)

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 7.5-9.5%

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 IDNCT01769378

Org study ID13193

Secondary IDH9X-MC-GBDGEli Lilly and Company

Timeline

Milestones

Study first posted2013-01-16estimated

Results first posted2015-10-14estimated

Last update posted2016-01-25estimated

Study start2013-01 (month precision)

Primary completion2014-12actual (month precision)

Study completion2014-12actual (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

•Type 2 diabetes mellitus

•Stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit

•Have an HbA1c value of ≥7.5% and ≤9.5%, as determined by the central laboratory draw performed at the first study visit

•Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol

•Men and nonpregnant women aged ≥18 years

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

•Body Mass Index (BMI) ≤45 kilograms per square meter (kg/m^2)

Exclusion criteria

•Have type 1 diabetes mellitus

•Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 3 months prior to the first study visit

•Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin within 3 months prior to the first study visit is exclusionary

•Have been treated with drugs that promote weight loss within 3 months prior to the first study visit

•Are receiving chronic (>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit

•Have had any of the following Cardiovascular (CV) conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident

•Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery

•Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level >2.5 times the upper limit of normal

•Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit

•Have an estimated glomerular filtration rate [eGFR] <30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2), calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation as determined by the central laboratory at the first study visit

•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 (this exclusion includes those participants with a family history of MEN 2A or 2B, whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)

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

•Have a serum calcitonin ≥20 picogram per milliliter (pg/mL) as determined by the central laboratory at the first study visit

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

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Reported and Adjudicated Cardiovascular Events

Time frame:Baseline through 24 Weeks, 30-day Follow Up

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Non-fatal MI, Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any)

Posted result

Group	Value (number), participants	95% CI
DulaglutideAny reported CV events	2	—
Any adjudicated nonfatal CV events	2	—
Any confirmed adjudicated CV deaths	0	—
PlaceboAny reported CV events	0	—
Any adjudicated nonfatal CV events	0	—
Any confirmed adjudicated CV deaths	0	—

Secondary/protocol endpoint

Number of Participants With Reported and Adjudicated Cardiovascular Events

Time frame:Baseline through 24 Weeks, 30-day Follow Up

Expanded / custom MACE composite

composite event, event

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

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight at 24 Weeks

Time frame:Baseline, 24 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
Dulaglutide	-0.91	—
Placebo	-0.24	—

Least Squares Mean Difference-0.6895% CI-1.53 – 0.18p0.120Mixed Models Analysis

Secondary/registry result

Change From Baseline in Body Mass Index (BMI) at 24 Weeks

Time frame:Baseline, 24 Weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms per/square meter kg/m^2	95% CI
Dulaglutide	-0.32	—
Placebo	-0.10	—

Least Squares Mean Difference-0.2395% CI-0.54 – 0.09p0.161Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at 24 Weeks

Time frame:Baseline, 24 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) at 24 Weeks

Time frame:Baseline, 24 Weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Primary/registry result

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks

Time frame:Baseline, 24 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percent change of HbA1c	95% CI
Dulaglutide	-1.38	—
Placebo	-0.11	—

LS Squares Mean Difference-1.2795% CI-1.57 – -0.97p<0.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks

Time frame:Baseline, 24 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks

Time frame:24 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
DulaglutidePercent Achieved <7.0 HbA1c Level	55.3	—
Percent Achieved ≤6.5 HbA1c Level	40.0	—
PlaceboPercent Achieved <7.0 HbA1c Level	18.9	—
Percent Achieved ≤6.5 HbA1c Level	9.4	—

Odds Ratio (OR)11.3795% CI3.82 – 33.84p<0.001Regression, Logistic

\<7.0% HbA1c

Odds Ratio (OR)11.4595% CI3.71 – 35.34p<0.001Regression, Logistic

≤6.5% HbA1c

Secondary/registry result

Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks

Time frame:Baseline, 24 Weeks

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	-30.60	—
Placebo	2.93	—

Least Squares Mean Difference-33.5495% CI-46.55 – -20.53p<0.001ANCOVA

Secondary/registry result

Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks

Time frame:Baseline, 24 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Dulaglutide	-37.22	—
Placebo	-8.27	—

Least Squares Mean Difference-28.9595% CI-38.49 – -19.40p<0.001Mixed Models Analysis

Secondary/registry result

Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia

Time frame:Baseline through 24 Weeks

time to event, event

Posted result

Group	Value (mean), weeks	95% CI
Dulaglutide	22.59	—
Placebo	22.47	—

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks

Time frame:24 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks

Time frame:Baseline, 24 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks

Time frame:Baseline, 24 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia

Time frame:Baseline through 24 Weeks

time to event, event

Safety / tolerability / PK

16 endpoints

Secondary/registry result

Number of Participants With Adjudicated Acute Pancreatitis Events

Time frame:Baseline through 24 Weeks, 30-day Follow Up

Pancreatitis

event count, event

Posted result

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

Secondary/registry result

Change From Baseline in Calcitonin at 24 Weeks

Time frame:Baseline, 24 Weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (median), picogram per milliliter (pg/ml)	95% CI
Dulaglutide	0.00	0.00 – 0.00
Placebo	0.00	0.00 – 0.00

Secondary/registry result

Percentage of Participants With Self-Reported Events of Hypoglycemia

Time frame:Baseline through 24 Weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
DulaglutideSymptomatic	11.3	—
Asymptomatic	13.4	—
Probable	2.5	—
Severe	0	—
Nocturnal	6.7	—
PlaceboSymptomatic	1.7	—
Asymptomatic	1.7	—
Probable	0.0	—
Severe	0	—
Nocturnal	1.7	—

Secondary/registry result

Rate of HE Adjusted Per 30 Days

Time frame:Baseline through 24 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), number of events/participants/30 days	95% CI
DulaglutideTotal HE	0.19	—
Documented symptomatic HE	0.07	—
Asymptomatic HE	0.11	—
Severe HE	0	—
Nocturnal HE	0.02	—
Probable symptomatic HE	0.01	—
PlaceboTotal HE	0.01	—
Documented symptomatic HE	0.00	—
Asymptomatic HE	0.00	—
Severe HE	0	—
Nocturnal HE	0.00	—
Probable symptomatic HE	0	—

Secondary/registry result

Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia

Time frame:Baseline through 24 Weeks

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Dulaglutide	2.1	—
Placebo	11.7	—

Secondary/registry result

Dulaglutide Anti-Drug Antibodies (ADA)

Time frame:Baseline up to 4 Weeks Post-Last Dose of Study Drug

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
Dulaglutide	2	—

Secondary/registry result

Change From Baseline in Lipase

Time frame:Baseline, 24 Weeks

change from baseline, descriptive

Posted result

Group	Value (median), Units/Liter	95% CI
Dulaglutide	8.0	1.0 – 18.0
Placebo	4.5	-2.5 – 15.5

Secondary/registry result

Change From Baseline in Amylase

Time frame:Baseline, 24 Weeks

change from baseline, descriptive

Posted result

Group	Value (median), Units/Liter	95% CI
Dulaglutide	8.0	1.0 – 18.0
Placebo	2.0	-5.0 – 11.0

Secondary/protocol endpoint

Number of Participants With Adjudicated Acute Pancreatitis Events

Time frame:Baseline through 24 Weeks, 30-day Follow Up

Pancreatitis

event count, event

Secondary/protocol endpoint

Change From Baseline in Calcitonin at 24 Weeks

Time frame:Baseline, 24 Weeks

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Percentage of Participants With Self-Reported Events of Hypoglycemia

Time frame:Baseline through 24 Weeks

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Rate of HE Adjusted Per 30 Days

Time frame:Baseline through 24 weeks

event count, event

Secondary/protocol endpoint

Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia

Time frame:Baseline through 24 Weeks

threshold achievement, event

Secondary/protocol endpoint

Dulaglutide Anti-Drug Antibodies (ADA)

Time frame:Baseline up to 4 Weeks Post-Last Dose of Study Drug

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Change From Baseline in Lipase

Time frame:Baseline, 24 Weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Amylase

Time frame:Baseline, 24 Weeks

change from baseline, descriptive

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

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

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.