AWARD-10

CompletedPhase 3Results posted

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

A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

424

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7-9.5%

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 IDNCT02597049

Org study ID15361

Secondary ID2015-002095-24

Secondary IDH9X-MC-GBGEEli Lilly and Company

Timeline

Milestones

Study first posted2015-11-04estimated

Results first posted2018-04-27actual

Last update posted2020-06-17actual

Study start2015-11 (month precision)

Primary completion2017-02actual (month precision)

Study completion2017-02actual (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 mellitus (based on the World Health Organization's [WHO] diagnostic criteria)

•Have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry (minimum required doses for that period for allowed SGLT2 inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg [per country-specific label], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500 mg/day and must be reached (or highest tolerated dose which is acceptable with documented gastrointestinal [GI] intolerability)

•Daily doses of all allowed oral antihyperglycemia agent (OAMs) must have been stable for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses of SGLT2 inhibitor and metformin, if used, will be considered stable during this period if:

–all prescribed daily doses were in the range between the minimum required dose and maximum-approved dose per country-specific label; and

–>90% of prescribed daily doses were equal to the dose at randomization

•Have HbA1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to randomization

•Have body mass index (BMI) ≤45 kilograms per meter squared (kg/m^2) and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment

Exclusion criteria

•Have type 1 diabetes mellitus

•Have been treated with any other OAMs (other than SGLT2 inhibitors and metformin), glucagon-like peptide-1 receptor agonist (GLP-1 RA), pramlintide or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary

•Have any condition that is a contraindication for use of the GLP-1 RA class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization

•Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial

•Had chronic or acute pancreatitis any time prior to study entry

•Estimated glomerular filtration rate (eGFR) <45 milliliters(mL)/minute/1.73m^2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead in

•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 participants with a family history of MEN 2A or 2B, whose family history for the syndrome is rearranged during transfect [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 the 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 picograms/mL as determined by the central laboratory at study entry

Endpoints (22)

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

Cardiovascular outcomes

Weight & body composition

Other (unclassified)

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Adjudicated Cardiovascular (CV) Events

Time frame:Baseline through 24 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 (count_of_participants), Participants	95% CI
1.5 mg DulaglutideAny CV Event	0	—
Fatal CV Event	0	—
Non-fatal CV Event	0	—
0.75 mg DulaglutideAny CV Event	0	—
Fatal CV Event	0	—
Non-fatal CV Event	0	—
PlaceboAny CV Event	3	—
Fatal CV Event	0	—
Non-fatal CV Event	3	—

Secondary/protocol endpoint

Number of Participants With Adjudicated Cardiovascular (CV) Events

Time frame:Baseline through 24 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

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight at 24 Weeks

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
1.5 mg DulaglutideTreatment-regimen Estimand	-3.1	—
Efficacy Estimand	-3.1	—
0.75 mg DulaglutideTreatment-regimen Estimand	-2.6	—
Efficacy Estimand	-2.6	—
PlaceboTreatment-regimen Estimand	-2.1	—
Efficacy Estimand	-2.3	—

Mean Difference (Final Values)-0.995% CI-1.8 – -0.1p0.027Mixed Models Analysis

Treatment-regimen Estimand

Mean Difference (Final Values)-0.595% CI-1.3 – 0.4p0.264Mixed Models Analysis

Treatment-regimen Estimand

Mean Difference (Final Values)-0.895% CI-1.7 – 0.0p0.059Mixed Models Analysis

Efficacy Estimand

Mean Difference (Final Values)-0.395% CI-1.2 – 0.5p0.435Mixed Models Analysis

Efficacy Estimand

Secondary/protocol endpoint

Change From Baseline in Body Weight at 24 Weeks

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

13 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)

Time frame:Baseline, Week 24

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	-1.34	—
0.75 mg Dulaglutide	-1.21	—
Placebo	-0.54	—

Mean Difference (Final Values)-0.7995% CI-0.97 – -0.61p<.001Mixed Models Analysis

Mean Difference (Final Values)-0.6695% CI-0.84 – -0.49p< .001Mixed Models Analysis

Primary/registry result

Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)

Time frame:Baseline, Week 24

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	-1.33	—
0.75 mg Dulaglutide	-1.19	—
Placebo	-0.51	—

Mean Difference (Final Values)-0.8295% CI-1.00 – -0.64p<.001Mixed Models Analysis

Mean Difference (Final Values)-0.6995% CI-0.86 – -0.51p<.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants With HbA1c <7%

Time frame:24 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 mg DulaglutideTreatment-regimen Estimand	71.21	—
Efficacy Estimand	71.54	—
0.75 mg DulaglutideTreatment-regimen Estimand	60.45	—
Efficacy Estimand	61.83	—
PlaceboTreatment-regimen Estimand	31.58	—
Efficacy Estimand	32.52	—

p< .001Regression, Logistic

Treatment-regimen Estimand

p< .001Regression, Logistic

Treatment-regimen Estimand

p< .001Regression, Logistic

Efficacy Estimand

p< .001Regression, Logistic

Efficacy Estimand

Secondary/registry result

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

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligram/deciliter (mg/dL)	95% CI
1.5 mg DulaglutideTreatment-regimen Estimand	-31.6	—
Efficacy Estimand	-31.9	—
0.75 mg DulaglutideTreatment-regimen Estimand	-26.5	—
Efficacy Estimand	-26.0	—
PlaceboTreatment-regimen Estimand	-6.9	—
Efficacy Estimand	-5.3	—

Mean Difference (Final Values)-24.795% CI-30.8 – -18.6p< .001ANCOVA

Treatment-regimen Estimand

Mean Difference (Final Values)-19.695% CI-25.7 – -13.5p<0.001ANCOVA

Treatment-regimen Estimand

Mean Difference (Final Values)-26.695% CI-32.7 – -20.6p<0.001ANCOVA

Efficacy Estimand

Mean Difference (Final Values)-20.795% CI-26.7 – -14.6p<0.001ANCOVA

Efficacy Estimand

Secondary/registry result

Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
1.5 mg DulaglutidePre-morning Morning Meal	-27.8	—
2-Hour Postprandial Morning Meal	-44.6	—
Pre-Mid Day Meal	-26.0	—
2-Hour Postprandial Mid Day Meal	-31.8	—
Pre-Evening Meal	-30.3	—
2-Hour Postprandial Evening Meal	-36.0	—
0.75 mg DulaglutidePre-morning Morning Meal	-23.2	—
2-Hour Postprandial Morning Meal	-41.1	—
Pre-Mid Day Meal	-22.0	—
2-Hour Postprandial Mid Day Meal	-25.5	—
Pre-Evening Meal	-30.1	—
2-Hour Postprandial Evening Meal	-30.6	—
PlaceboPre-morning Morning Meal	-8.1	—
2-Hour Postprandial Morning Meal	-20.1	—
Pre-Mid Day Meal	-7.7	—
2-Hour Postprandial Mid Day Meal	-12.8	—
Pre-Evening Meal	-7.5	—
2-Hour Postprandial Evening Meal	-13.9	—

Mean Difference (Final Values)-19.795% CI-25.7 – -13.8p< .001Mixed Models Analysis

Pre-morning meal.

Mean Difference (Final Values)-15.295% CI-21.2 – -9.2p< .001Mixed Models Analysis

Pre-morning meal

Mean Difference (Final Values)-24.595% CI-33.8 – -15.3p< .001Mixed Models Analysis

2-hour postprandial

Mean Difference (Final Values)-21.195% CI-30.3 – -11.8p< .001Mixed Models Analysis

2-hour postprandial

Mean Difference (Final Values)-18.395% CI-26.4 – -10.2p< .001Mixed Models Analysis

Pre-midday meal

Mean Difference (Final Values)-14.395% CI-22.5 – -6.2p< .001Mixed Models Analysis

Pre-midday meal

Mean Difference (Final Values)-19.095% CI-28.8 – -9.3p< .001Mixed Models Analysis

2-hour postprandial after midday meal

Mean Difference (Final Values)-12.895% CI-22.5 – -3.1p0.010Mixed Models Analysis

2-hour postprandial after midday meal

Mean Difference (Final Values)-22.795% CI-30.7 – -14.7p< .001Mixed Models Analysis

Pre-evening meal

Mean Difference (Final Values)-22.595% CI-30.7 – -14.4p< .001Mixed Models Analysis

Pre-evening meal

Mean Difference (Final Values)-22.195% CI-31.4 – -12.9p< .001Mixed Models Analysis

2-hour postprandial after evening meal

Mean Difference (Final Values)-16.795% CI-26.0 – -7.4p< .001Mixed Models Analysis

2-hour postprandial after evening meal

Secondary/registry result

Change From Baseline in Fasting Glucagon at 24 Weeks

Time frame:Baseline, Week 24

fasting glucagon

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picomole per liter (pmol/L)	95% CI
1.5 mg DulaglutideTreatment-regimen Estimand	-2.1	—
Efficacy Estimand	-2.2	—
0.75 mg DulaglutideTreatment-regimen Estimand	-1.5	—
Efficacy Estimand	-1.4	—
PlaceboTreatment-regimen Estimand	-0.9	—
Efficacy Estimand	-0.9	—

Mean Difference (Final Values)-1.295% CI-2.3 – -0.1p0.032ANCOVA

Treatment-regimen Estimand

Mean Difference (Final Values)-0.695% CI-1.7 – 0.5p0.273ANCOVA

Treatment-regimen Estimand

Mean Difference (Final Values)-1.395% CI-2.4 – -0.2p0.023ANCOVA

Efficacy Estimand

Mean Difference (Final Values)-0.695% CI-1.7 – 0.6p0.320ANCOVA

Efficacy Estimand

Secondary/registry result

Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia

Time frame:Baseline through 24 Weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
1.5 mg Dulaglutide	0	—
0.75 mg Dulaglutide	3	—
Placebo	2	—

Secondary/protocol endpoint

Percentage of Participants With HbA1c <7%

Time frame:24 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia

Time frame:Baseline through 24 Weeks

event count, event

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Rate of Hypoglycemic Events Adjusted Per 30 Days

Time frame:Baseline through 24 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), Number of events/participant/30 days	95% CI
1.5 mg DulaglutideTotal Hypoglycemia	0.026	—
Documented Symptomatic Hypoglycemia	0.013	—
Asymptomatic Hypoglycemia	0.013	—
Probable Symptomatic	0.000	—
Relative Hypoglycemia	0.003	—
Nocturnal Hypoglycemia	0.002	—
0.75 mg DulaglutideTotal Hypoglycemia	0.022	—
Documented Symptomatic Hypoglycemia	0.013	—
Asymptomatic Hypoglycemia	0.008	—
Probable Symptomatic	0.001	—
Relative Hypoglycemia	0.001	—
Nocturnal Hypoglycemia	0.009	—
PlaceboTotal Hypoglycemia	0.017	—
Documented Symptomatic Hypoglycemia	0.010	—
Asymptomatic Hypoglycemia	0.006	—
Probable Symptomatic	0.001	—
Relative Hypoglycemia	0.005	—
Nocturnal Hypoglycemia	0.000	—

Secondary/registry result

Number of Participants With Adjudicated Acute Pancreatitis Events

Time frame:Baseline through 24 Weeks

Pancreatitis

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
1.5 mg Dulaglutide	0	—
0.75 mg Dulaglutide	0	—
Placebo	0	—

Secondary/protocol endpoint

Rate of Hypoglycemic Events Adjusted Per 30 Days

Time frame:Baseline through 24 Weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Adjudicated Acute Pancreatitis Events

Time frame:Baseline through 24 Weeks

Pancreatitis

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change From Baseline in Fasting Glucagon at 24 Weeks

Time frame:Baseline, Week 24

change from baseline, improvement

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

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
Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial.
The lancet. Diabetes & endocrinology2018 May (month)PMID29483060doi:10.1016/S2213-8587(18)30023-8via clinicaltrials gov reference derived + pubmed nct search
Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial.
The lancet. Diabetes & endocrinology2016 Dec (month)PMID27651331doi:10.1016/S2213-8587(16)30267-4via 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.