AWARD-7

CompletedPhase 3Results posted

A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)

A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-weekly Dulaglutide With Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes and Moderate or Severe Chronic Kidney Disease

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

577

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

•BMI 23-45•HbA1c 7.5-10.5%•eGFR 15-60

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 IDNCT01621178

Org study ID13798

Secondary ID2012-000829-44

Secondary IDH9X-MC-GBDXEli Lilly and Company

Timeline

Milestones

Study first posted2012-06-18estimated

Results first posted2017-07-24actual

Last update posted2019-09-19actual

Study start2012-07 (month precision)

Primary completion2016-06actual (month precision)

Study completion2016-12actual (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men and non-pregnant women aged ≥18 years

•Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%

•Type 2 diabetes on insulin or insulin + oral antihyperglycemic medication

•Participants with presumed diabetic kidney disease with or without hypertensive nephrosclerosis diagnosed with moderate or severe CKD with estimated glomerular filtration rate (eGFR) of ≥15 to <60 milliliters per minute (mL/min)/1.73 meter squared (m^2)

•Able and willing to perform multiple daily injections

•Body mass index (BMI) between 23 and 45 kilogram/square meter (kg/m^2)

Exclusion criteria

•Stage 5 CKD as defined by eGFR <15 mL/min/1.73 m^2 OR having required dialysis

•Rapidly progressing renal dysfunction likely to require renal replacement

•History of a transplanted organ

•Type 1 diabetes mellitus

•At screening a systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥90 mmHg with or without antihypertensive medication

•An episode of ketoacidosis or hyperosmolar state/coma in the past 6 months or a history of severe hypoglycemia in the past 3 months prior to the Screening Visit

•Cardiovascular conditions within 12 weeks prior to randomization: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)

•Acute or chronic hepatitis

•Signs and symptoms of chronic or acute pancreatitis, or were in the past diagnosed with pancreatitis

•Serum calcitonin ≥35 picograms per milliliter (pg/mL) at Screening Visit

•Self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma

•Known history of untreated proliferative retinopathy

Endpoints (58)

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

Renal / kidney

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 26 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
Insulin Glargine	1.11	—
Dulaglutide 0.75 mg	-2.02	—
Dulaglutide 1.5 mg	-2.81	—

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 52 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Insulin Glargine	1.57	—
Dulaglutide 0.75 mg	-1.71	—
Dulaglutide 1.5 mg	-2.66	—

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 26 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 52 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

28 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 26 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Insulin Glargine	-1.13	—
Dulaglutide 0.75 mg	-1.12	—
Dulaglutide 1.5 mg	-1.19	—

Mean Difference (Final Values)-0.0595% CI-0.26 – 0.15p<0.001Mixed Models Analysis

Week 26

Mean Difference (Final Values)0.0295% CI-0.18 – 0.22p<0.001Mixed Models Analysis

Week 26

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 26 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Whose HbA1c Was <7.0%

Time frame:26 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	34.6	—
Dulaglutide 0.75 mg	31.7	—
Dulaglutide 1.5 mg	37.5	—

Secondary/registry result

Percentage of Participants Whose HbA1c Was <8.0%

Time frame:26 Weeks

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	75.3	—
Dulaglutide 0.75 mg	72.6	—
Dulaglutide 1.5 mg	78.3	—

Secondary/registry result

Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)

Time frame:Baseline, 26 Weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams/deciliter (mg/dL)	95% CI
Insulin Glargine	-37.6	—
Dulaglutide 0.75 mg	-31.7	—
Dulaglutide 1.5 mg	-33.7	—

Secondary/registry result

Change From Baseline in Fasting Glucose (FG)

Time frame:Baseline, 26 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligram/deciliter (mg/dL)	95% CI
Insulin Glargine	-19.1	—
Dulaglutide 0.75 mg	17.7	—
Dulaglutide 1.5 mg	23.1	—

Secondary/registry result

Change From Baseline in Mean Daily Insulin Lispro Dose

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units/day (U/day)	95% CI
Insulin Glargine	16.64	—
Dulaglutide 0.75 mg	26.16	—
Dulaglutide 1.5 mg	18.12	—

Secondary/registry result

Percentage of Participants With Estimated Average Glucose <154 mg/dL

Time frame:26 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	64.9	—
Dulaglutide 0.75 mg	52.5	—
Dulaglutide 1.5 mg	56.4	—

Secondary/registry result

Change From Baseline in HbA1c

Time frame:Baseline, 52 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Insulin Glargine	-1.00	—
Dulaglutide 0.75 mg	-1.10	—
Dulaglutide 1.5 mg	-1.10	—

Secondary/registry result

Percentage of Participants Whose HbA1c is <7.0%

Time frame:52 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	29.1	—
Dulaglutide 0.75 mg	33.5	—
Dulaglutide 1.5 mg	32.9	—

Secondary/registry result

Percentage of Participants Whose HbA1c is <8.0%

Time frame:52 Weeks

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	70.3	—
Dulaglutide 0.75 mg	69.5	—
Dulaglutide 1.5 mg	69.1	—

Secondary/registry result

Change From Baseline in 8-Point SMPG

Time frame:Baseline, 52 Weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Insulin Glargine	-40.5	—
Dulaglutide 0.75 mg	-30.0	—
Dulaglutide 1.5 mg	-27.2	—

Secondary/registry result

Change From Baseline in FG

Time frame:Baseline, 52 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Insulin Glargine	-6.4	—
Dulaglutide 0.75 mg	20.8	—
Dulaglutide 1.5 mg	28.3	—

Secondary/registry result/low confidence

Change in Mean Daily Insulin Lispro Dose

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), U/day	95% CI
Insulin Glargine	16.84	—
Dulaglutide 0.75 mg	27.46	—
Dulaglutide 1.5 mg	20.05	—

Secondary/registry result

Percentage of Participants With Estimated Average Glucose <154 mg/dL

Time frame:52 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine	73.7	—
Dulaglutide 0.75 mg	57.4	—
Dulaglutide 1.5 mg	50.9	—

Secondary/protocol endpoint

Percentage of Participants Whose HbA1c Was <7.0%

Time frame:26 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Whose HbA1c Was <8.0%

Time frame:26 Weeks

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)

Time frame:Baseline, 26 Weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Glucose (FG)

Time frame:Baseline, 26 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Mean Daily Insulin Lispro Dose

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Estimated Average Glucose <154 mg/dL

Time frame:26 Weeks

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in HbA1c

Time frame:Baseline, 52 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Whose HbA1c is <7.0%

Time frame:52 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Whose HbA1c is <8.0%

Time frame:52 Weeks

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in 8-Point SMPG

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in FG

Time frame:Baseline, 52 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Mean Daily Insulin Lispro Dose

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Estimated Average Glucose <154 mg/dL

Time frame:52 Weeks

threshold achievement, improvement

Renal / kidney

16 endpoints

Secondary/registry result

Change From Baseline in Serum Creatinine (sCr)

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Posted result

Group	Value (median), mg/dL	95% CI
Insulin Glargine	0.10	-0.04 – 0.28
Dulaglutide 0.75 mg	0.02	-0.15 – 0.15
Dulaglutide 1.5 mg	0.04	-0.14 – 0.20

Secondary/registry result

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline, 26 Weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Posted result

Group	Value (median), milliliter/minute/1.73m2 (mL/min/1.73m2)	95% CI
Insulin Glargine	-2.5	-6.0 – 1.0
Dulaglutide 0.75 mg	-1.0	-4.5 – 3.0
Dulaglutide 1.5 mg	-1.0	-5.5 – 3.0

Secondary/registry result

Change From Baseline in Estimated Creatinine Clearance (eCrCl)

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Posted result

Group	Value (median), milliliter/minute (ml/min)	95% CI
Insulin Glargine	-2.0	-4.0 – 0.5
Dulaglutide 0.75 mg	-1.0	-3.5 – 2.0
Dulaglutide 1.5 mg	-0.5	-4.0 – 2.0

Secondary/registry result

Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)

Time frame:Baseline, 26 Weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Posted result

Group	Value (median), gram/kilogram (g/kg)	95% CI
Insulin Glargine	-1.3	-71.7 – 62.0
Dulaglutide 0.75 mg	-11.1	-147.8 – 33.2
Dulaglutide 1.5 mg	-10.2	-180.5 – 53.1

Secondary/registry result

Change From Baseline in sCr

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Posted result

Group	Value (median), mg/dL	95% CI
Insulin Glargine	0.12	-0.05 – 0.38
Dulaglutide 0.75 mg	0.04	-0.11 – 0.27
Dulaglutide 1.5 mg	0.07	-0.11 – 0.21

Secondary/registry result

Change From Baseline in eGFR

Time frame:Baseline, 52 Weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Posted result

Group	Value (median), mL/min/1.73m2	95% CI
Insulin Glargine	-3.3	-7.5 – 1.0
Dulaglutide 0.75 mg	-1.5	-5.5 – 2.5
Dulaglutide 1.5 mg	-2.0	-6.0 – 2.5

Secondary/registry result

Change From Baseline in eCrCl

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Posted result

Group	Value (median), mL/min	95% CI
Insulin Glargine	-2.5	-5.8 – 0.5
Dulaglutide 0.75 mg	-1.3	-4.0 – 1.5
Dulaglutide 1.5 mg	-1.5	-5.0 – 1.5

Secondary/registry result

Change From Baseline in UACR

Time frame:Baseline, 52 Weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Posted result

Group	Value (median), g/kg	95% CI
Insulin Glargine	3.5	-56.2 – 138.1
Dulaglutide 0.75 mg	-3.0	-88.5 – 87.6
Dulaglutide 1.5 mg	-11.5	-158.0 – 42.9

Secondary/protocol endpoint

Change From Baseline in Serum Creatinine (sCr)

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline, 26 Weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change From Baseline in Estimated Creatinine Clearance (eCrCl)

Time frame:Baseline, 26 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)

Time frame:Baseline, 26 Weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

Change From Baseline in sCr

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in eGFR

Time frame:Baseline, 52 Weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change From Baseline in eCrCl

Time frame:Baseline, 52 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in UACR

Time frame:Baseline, 52 Weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Safety / tolerability / PK

10 endpoints

Secondary/registry result

Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin GlargineTotal Hypo	71.6	—
Documented Symptomatic Hypo	60.3	—
Severe Hypo	4.1	—
Nocturnal Hypo	38.1	—
Dulaglutide 0.75 mgTotal Hypo	50.8	—
Documented Symptomatic Hypo	40.7	—
Severe Hypo	1.1	—
Nocturnal Hypo	15.9	—
Dulaglutide 1.5 mgTotal Hypo	43.2	—
Documented Symptomatic Hypo	31.6	—
Severe Hypo	0	—
Nocturnal Hypo	13.2	—

Secondary/registry result

Rate of Hypoglycemic Events

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), Events/Participant/Year	95% CI
Insulin GlargineTotal HE Rate	17.07	—
Documented Symptomatic HE Rate	11.34	—
Severe HE Rate	0.10	—
Nocturnal HE Rate	3.06	—
Dulaglutide 0.75 mgTotal HE Rate	7.76	—
Documented Symptomatic HE Rate	4.86	—
Severe HE Rate	0.03	—
Nocturnal HE Rate	0.73	—
Dulaglutide 1.5 mgTotal HE Rate	5.45	—
Documented Symptomatic HE Rate	4.19	—
Severe HE Rate	0.00	—
Nocturnal HE Rate	0.63	—

Secondary/registry result

Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Time frame:Baseline through 52 Weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin GlargineTotal Hypo	74.7	—
Documented Symptomatic Hypo	63.4	—
Severe Hypo	6.7	—
Nocturnal Hypo	47.9	—
Dulaglutide 0.75 mgTotal Hypo	59.8	—
Documented Symptomatic Hypo	48.1	—
Severe Hypo	2.6	—
Nocturnal Hypo	23.8	—
Dulaglutide 1.5 mgTotal Hypo	50.0	—
Documented Symptomatic Hypo	40.5	—
Severe Hypo	0	—
Nocturnal Hypo	20.5	—

Secondary/registry result

Rate of Hypoglycemic Events (HE)

Time frame:Baseline through 52 Weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), Events/Participant/Year	95% CI
Insulin GlargineTotal HE Rate	14.36	—
Documented Symptomatic HE Rate	9.62	—
Severe HE Rate	0.09	—
Nocturnal HE Rate	2.48	—
Dulaglutide 0.75 mgTotal HE Rate	7.59	—
Documented Symptomatic HE Rate	4.34	—
Severe HE Rate	0.03	—
Nocturnal HE Rate	0.76	—
Dulaglutide 1.5 mgTotal HE Rate	5.82	—
Documented Symptomatic HE Rate	4.44	—
Severe HE Rate	0.00	—
Nocturnal HE Rate	0.70	—

Secondary/registry result

Participants With Events of Allergic/Hypersensitivity Reactions

Time frame:Baseline through 52 Weeks

event count, event

componentsangioedema smq, anaphylactic reaction smq, severe cutaneous adverse reactions smq

Posted result

Group	Value (number), participants with events	95% CI
Insulin GlargineAngioedema SMQ	1	—
Angioedema	0	—
Eyelid edema	0	—
Face edema	0	—
Urticaria	1	—
Anaphylactic Reaction SMQ	1	—
Circulatory collapse	1	—
Severe Cutaneous Adverse Reactions SMQ	0	—
Dulaglutide 0.75 mgAngioedema SMQ	2	—
Angioedema	0	—
Eyelid edema	1	—
Face edema	1	—
Urticaria	0	—
Anaphylactic Reaction SMQ	0	—
Circulatory collapse	0	—
Severe Cutaneous Adverse Reactions SMQ	0	—
Dulaglutide 1.5 mgAngioedema SMQ	2	—
Angioedema	1	—
Eyelid edema	0	—
Face edema	1	—
Urticaria	0	—
Anaphylactic Reaction SMQ	0	—
Circulatory collapse	0	—
Severe Cutaneous Adverse Reactions SMQ	0	—

Secondary/protocol endpoint

Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Rate of Hypoglycemic Events

Time frame:Baseline through 26 Weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

Time frame:Baseline through 52 Weeks

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Rate of Hypoglycemic Events (HE)

Time frame:Baseline through 52 Weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Participants With Events of Allergic/Hypersensitivity Reactions

Time frame:Baseline through 52 Weeks

event count, event

componentsangioedema smq, anaphylactic reaction smq, severe cutaneous adverse reactions smq

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

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial.
The lancet. Diabetes & endocrinology2018 Aug (month)PMID29910024doi:10.1016/S2213-8587(18)30104-9via 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.