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)
AWARD-7
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
3 other identifiers
interventional
577
9 countries
89
Brief Summary
The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Jul 2012
Longer than P75 for phase_3 type-2-diabetes
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 18, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
July 24, 2017
CompletedSeptember 19, 2019
September 1, 2019
3.9 years
June 14, 2012
June 21, 2017
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment\*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.
Baseline, 26 Weeks
Secondary Outcomes (28)
Percentage of Participants Whose HbA1c Was <7.0%
26 Weeks
Percentage of Participants Whose HbA1c Was <8.0%
26 Weeks
Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)
Baseline, 26 Weeks
Change From Baseline in Fasting Glucose (FG)
Baseline, 26 Weeks
Change From Baseline in Mean Daily Insulin Lispro Dose
Baseline, 26 Weeks
- +23 more secondary outcomes
Study Arms (3)
Insulin glargine
ACTIVE COMPARATORInsulin glargine was administered subcutaneously (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
0.75 mg Dulaglutide
EXPERIMENTAL0.75 milligram (mg) of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
1.5 mg Dulaglutide
EXPERIMENTAL1.5 mg of dulaglutide was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
Extended Arm Physician, Inc.
Montgomery, Alabama, 36106, United States
North American Research Institute
Azusa, California, 91702, United States
Renal Consultants Medical Group
Granada Hills, California, 91344, United States
Marin Endocrine Associates
Greenbrae, California, 94904, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Sutter Gould Medical Foundation
Modesto, California, 95355, United States
Infosphere
West Hills, California, 91307, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
The Center for Diabetes & Endocrine Care
Hollywood, Florida, 33312, United States
East Coast Clinical Research
Jacksonville, Florida, 32204, United States
San Marcus Research Clinic, Inc.
Miami, Florida, 33015, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
Avanced Medical and Pain Mangement Research Clinic (AMPM)
Miami, Florida, 33145, United States
Baptist Diabetes Association
Miami, Florida, 33156, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Discovery Medical Research Group
Ocala, Florida, 34471, United States
Suncoast Clinical Research
Palm Harbor, Florida, 34684, United States
University of Hawaii Clinical Research
Honolulu, Hawaii, 96813, United States
Boise Kidney & Hypertension Institute
Caldwell, Idaho, 83605, United States
Pacific Renal Research Institute
Meridian, Idaho, 83642, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Univ of Kansas Schl of Medicine , Wichita
Wichita, Kansas, 67214, United States
Penobscot Bay Medical Center
Rockport, Maine, 04854, United States
Nebraska Nephrology Research Institute, LLC
Lincoln, Nebraska, 68510, United States
Endocrine Group, LLP
Albany, New York, 12206, United States
Erie County Medical Center State University
Buffalo, New York, 14215, United States
Institute for clinical studies
Rosedale, New York, 11422, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, 11787, United States
Carolina Clinical Trials LLC
Concord, North Carolina, 28025, United States
Physicians East
Greenville, North Carolina, 27834, United States
Diabetes & Endocrinology Consultants PC
Morehead City, North Carolina, 28557, United States
Boice Willis Clinic, PA
Rocky Mount, North Carolina, 27804, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Partners in Nephrology & Endocrinology
Pittsburgh, Pennsylvania, 15224, United States
South Carolina Nephrology and Hypertension Center, Inc.
Orangeburg, South Carolina, 29118, United States
Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist
Sumter, South Carolina, 29150, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923, United States
Center For Clinical Research
Austin, Texas, 78758, United States
Endocrine Associates of Dallas
Dallas, Texas, 75231, United States
Office of Dr. Sergio Rovner
El Paso, Texas, 79925, United States
Endocrine Associates, LLC
Houston, Texas, 77004, United States
Juno Research
Houston, Texas, 77036, United States
The Endocrine Center
Houston, Texas, 77079, United States
San Antonio Kidney Disease Center Physicians Group
San Antonio, Texas, 78229, United States
Providence Health & Services
Spokane, Washington, 99204, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Belém, 66073-000, Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Curitiba, 80240-000, Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Juiz de Fora, 36036-330, Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Passo Fundo, 99010-080, Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Porto Alegre, 90610000, Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Catarina, 89227680, Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
São Paulo, 04025-011, Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Baja, 6500, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Budapest, 1036, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Esztergom, 2500, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kaposvár, 7400, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kecskemét, 6000, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pécs, 7623, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sátoraljaújhely, H-3980, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Siófok, 8600, Hungary
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chihuahua City, 31000, Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Culiacán, 80030, Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guadalajara, 44650, Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City, 11850, Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Monterrey, 64000, Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gdansk, 80-952, Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lodz, 90302, Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Szczecin, 70-111, Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Zgierz, 95-100, Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bacau, 600114, Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bucharest, 020045, Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Deva, 330084, Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Oradea, 410167, Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Târgu Mureş, 540142, Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Timișoara, 300125, Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cape Town, 7925, South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Durban, 4091, South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Johannesburg, 2198, South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Somerset West, 7130, South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Worcester, 6850, South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, 08036, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Valencia, 46026, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dnipropetrovsk, 49005, Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kyiv, 2091, Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Luhansk, 91045, Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Poltava, 36011, Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ternopil, 46002, Ukraine
Related Publications (2)
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
PMID: 39963952DERIVEDTuttle KR, Lakshmanan MC, Rayner B, Busch RS, Zimmermann AG, Woodward DB, Botros FT. 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. Lancet Diabetes Endocrinol. 2018 Aug;6(8):605-617. doi: 10.1016/S2213-8587(18)30104-9. Epub 2018 Jun 14.
PMID: 29910024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Dulaglutide dose was blinded to participant, care provider, investigator and outcomes assessor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2012
First Posted
June 18, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
September 19, 2019
Results First Posted
July 24, 2017
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.