AWARD-6

CompletedPhase 3Results posted

A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes

A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)

Lead sponsor

Eli Lilly and Company

Assets

Dulaglutide / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

599

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c ≥7%

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 IDNCT01624259

Org study ID11377

Secondary ID2011-003810-18

Secondary IDH9X-MC-GBDEEli Lilly and Company

Timeline

Milestones

Study first posted2012-06-20estimated

Last update posted2014-10-09estimated

Results first posted2014-10-09estimated

Study start2012-06 (month precision)

Primary completion2013-11actual (month precision)

Study completion2013-11actual (month precision)

Assets

Investigational agents

Dulaglutide Liraglutide

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

•Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit

•Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%

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

•Men and nonpregnant women aged greater than or equal to 18 years

•Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening

•Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m^2)

Exclusion criteria

•Have type 1 diabetes mellitus

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

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

•Are receiving chronic (greater than 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 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 (such as, 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 greater than or equal to 3 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 a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute)

•Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) 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, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)

•Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL)

Endpoints (46)

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

Cardiometabolic biomarkers

Weight & body composition

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Reported and Adjudicated Cardiovascular Events

Time frame:Baseline up to 26 Weeks

Expanded / custom MACE composite

composite event, 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
1.5 mg LY2189265Any reported CV events	0	—
Any adjudicated nonfatal CV events	0	—
Any confirmed adjudicated deaths	0	—
1.8 mg LiraglutideAny reported CV events	3	—
Any adjudicated nonfatal CV events	1	—
Any confirmed adjudicated deaths	0	—

Secondary/protocol endpoint

Number of Participants With Reported and Adjudicated Cardiovascular Events

Time frame:Baseline up to 26 Weeks

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 26 Weeks

Time frame:Baseline, Up to 26 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
1.5 mg LY2189265	-2.90	—
1.8 mg Liraglutide	-3.61	—

LS Mean Difference0.7195% CI0.17 – 1.26p0.010ANCOVA

Treatment comparison from ANCOVA model at 26 weeks.

Secondary/registry result

Change From Baseline in Body Mass Index (BMI) at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms/square meter (kg/m^2)	95% CI
1.5 mg LY2189265	-1.05	—
1.8 mg Liraglutide	-1.30	—

LS Mean Difference0.2595% CI0.05 – 0.45p0.013ANCOVA

Treatment comparison from ANCOVA model.

Secondary/protocol endpoint

Change From Baseline in Body Weight at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

13 endpoints

Primary/registry result

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 26 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated hemoglobin	95% CI
1.5 mg LY2189265	-1.42	—
1.8 mg Liraglutide	-1.36	—

LS Mean Difference-0.0695% CI-0.19 – 0.07p<0.001Mixed Models Analysis

LS Mean Difference-0.0695% CI-0.19 – 0.07p0.186Mixed Models Analysis

Superiority analysis

Primary/protocol endpoint

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 26 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams/deciliter (mg/dL)	95% CI
1.5 mg LY2189265	-34.81	—
1.8 mg Liraglutide	-34.25	—

LS Mean Difference-0.5795% CI-5.69 – 4.56p0.828ANCOVA

Treatment comparison from ANCOVA model.

Secondary/registry result

Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
1.5 mg LY2189265	-40.76	—
1.8 mg Liraglutide	-38.51	—

LS Mean Difference-2.2595% CI-5.91 – 1.41p0.228Mixed Models Analysis

Secondary/registry result

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks

Time frame:Up to 26 Weeks

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, HbA1c <7.0% achievement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg LY2189265HbA1c levels ≤6.5%	54.6	—
HbA1c levels <7.0%	68.3	—
1.8 mg LiraglutideHbA1c levels ≤6.5%	50.9	—
HbA1c levels <7.0%	67.9	—

Odds Ratio (OR)1.2395% CI0.81 – 1.86p0.322Regression, Logistic

Treatment comparison for HbA1c levels ≤6.5%

Odds Ratio (OR)1.0295% CI0.64 – 1.63p0.925Regression, Logistic

Treatment comparison for HbA1c levels \<7.0%.

Secondary/registry result

Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of HOMA2-%B	95% CI
1.5 mg LY2189265	37.03	—
1.8 mg Liraglutide	35.59	—

LS Mean Difference1.4395% CI-4.06 – 6.92p0.608ANCOVA

Secondary/registry result

Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia

Time frame:Baseline through 26 Weeks

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg LY2189265	0.3	—
1.8 mg Liraglutide	1.0	—

Secondary/registry result

Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia

Time frame:Baseline through 26 Weeks

time to event, event

Posted result

Group	Value (median), weeks	95% CI
1.5 mg LY2189265	NA	0.975 – 1.000
1.8 mg Liraglutide	NA	0.966 – 0.996

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks

Time frame:Baseline, 26 Weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks

Time frame:Up to 26 Weeks

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, HbA1c <7.0% achievement

Secondary/protocol endpoint

Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia

Time frame:Baseline through 26 Weeks

time to event, event

Cardiometabolic biomarkers

8 endpoints

Secondary/registry result

Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
1.5 mg LY2189265	1.9	—
1.8 mg Liraglutide	4.1	—

Secondary/registry result

Change From Baseline in Heart Rate (HR) at 26 Weeks

Time frame:Baseline, 26 Weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), bpm	95% CI
1.5 mg LY2189265	2.37	—
1.8 mg Liraglutide	3.12	—

Secondary/registry result

Change From Baseline in Blood Pressure (BP) at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milliliters of mercury (mmHg)	95% CI
1.5 mg LY2189265Sitting DBP	-0.22	—
Sitting SBP	-3.36	—
1.8 mg LiraglutideSitting DBP	-0.31	—
Sitting SBP	-2.82	—

Secondary/registry result

Percent Change From Baseline in Lipid Parameters at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

percent change from baseline, improvement

componentsTotal cholesterol, change, HDL-C, change, LDL-C, change, VLDL, change, Triglycerides, change

Posted result

Group	Value (least_squares_mean), percent	95% CI
LY2189265Total cholesterol (n=286, 284)	-1.64	—
HDL-C (n=286, 284)	6.21	—
LDL-C (n=276, 276)	-1.09	—
VLDL (n=276, 276)	1.56	—
Triglycerides (n=286, 284)	0.59	—
LiraglutideTotal cholesterol (n=286, 284)	0.67	—
HDL-C (n=286, 284)	6.46	—
LDL-C (n=276, 276)	3.20	—
VLDL (n=276, 276)	2.92	—
Triglycerides (n=286, 284)	1.35	—

Secondary/protocol endpoint

Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Heart Rate (HR) at 26 Weeks

Time frame:Baseline, 26 Weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Blood Pressure (BP) at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Lipid Parameters at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

percent change from baseline, improvement

Safety / tolerability / PK

19 endpoints

Secondary/registry result

Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), milliseconds (msec)	95% CI
1.5 mg LY2189265PR interval (n=270, 278)	3.8	—
QTcF interval (n=273, 284)	0.39	—
1.8 mg LiraglutidePR interval (n=270, 278)	3.3	—
QTcF interval (n=273, 284)	-0.72	—

Secondary/registry result

Number of Participants With Adjudicated Acute Pancreatitis Events

Time frame:Baseline up to 30 Weeks

Pancreatitis

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	0	—
1.8 mg Liraglutide	0	—

Secondary/registry result

Change From Baseline in Calcitonin at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (median), picograms/milliliter (pcg/mL)	95% CI
1.5 mg LY2189265	0.00	0.00 – 0.00
1.8 mg Liraglutide	0.00	0.00 – 0.00

Secondary/registry result

Change From Baseline in Lipase at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

change from baseline, descriptive

Posted result

Group	Value (median), units/liter (U/L)	95% CI
1.5 mg LY2189265	7.0	0.5 – 17.5
1.8 mg Liraglutide	11.0	2.0 – 23.0

Secondary/registry result

Change From Baseline in Amylase at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

change from baseline, descriptive

Posted result

Group	Value (median), U/L	95% CI
1.5 mg LY2189265	7.0	0.0 – 14.0
1.8 mg Liraglutide	6.0	0.0 – 13.0

Secondary/registry result

Percentage of Participants With Self-Reported Hypoglycemia Events

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg LY2189265Documented symptomatic HE	2.7	—
Asymptomatic HE	6.7	—
Severe HE	0.0	—
Nocturnal HE	1.3	—
Probable symptomatic HE	1.0	—
1.8 mg LiraglutideDocumented symptomatic HE	2.7	—
Asymptomatic HE	3.3	—
Severe HE	0.0	—
Nocturnal HE	2.0	—
Probable symptomatic HE	1.0	—

Secondary/registry result

Rate of Hypoglycemic Events Adjusted Per 30 Days

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), number of events/participant/30 days	95% CI
1.5 mg LY2189265Total HE	0.03	—
Documented symptomatic HE	0.01	—
Asymptomatic HE	0.02	—
Severe HE	0.00	—
Nocturnal HE	0.01	—
Probable symptomatic HE	0.00	—
1.8 mg LiraglutideTotal HE	0.04	—
Documented symptomatic HE	0.02	—
Asymptomatic HE	0.01	—
Severe HE	0.00	—
Nocturnal HE	0.01	—
Probable symptomatic HE	0.01	—

Secondary/registry result

Number of Participants With Allergic or Hypersensitivity Reactions

Time frame:Baseline through 26 Weeks

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 mg LY2189265	1	—
1.8 mg Liraglutide	5	—

Secondary/registry result

Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose

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
1.5 mg LY2189265	3	—

Secondary/protocol endpoint

Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks

Time frame:Baseline, 26 Weeks

change from baseline, descriptive

Secondary/protocol endpoint

Number of Participants With Adjudicated Acute Pancreatitis Events

Time frame:Baseline up to 30 Weeks

Pancreatitis

event count, event

Secondary/protocol endpoint

Change From Baseline in Calcitonin at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Lipase at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Amylase at 26 Weeks

Time frame:Baseline, Up to 26 Weeks

change from baseline, descriptive

Secondary/protocol endpoint

Percentage of Participants With Self-Reported Hypoglycemia Events

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia

Time frame:Baseline through 26 Weeks

threshold achievement, event

Secondary/protocol endpoint

Rate of Hypoglycemic Events Adjusted Per 30 Days

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Allergic or Hypersensitivity Reactions

Time frame:Baseline through 26 Weeks

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose

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

Immunogenicity (ADA)

threshold achievement, event

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

Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years.
Diabetes, obesity & metabolism2016 Aug (month)PMID27161178doi:10.1111/dom.12687via clinicaltrials gov reference derived + pubmed nct search
Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme.
Diabetes, obesity & metabolism2016 Apr (month)PMID26691396doi:10.1111/dom.12624via clinicaltrials gov reference derived + pubmed nct search
Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial.
Lancet (London, England)2014 Oct 11PMID25018121doi:10.1016/S0140-6736(14)60976-4via 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.