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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01621178
First received: June 14, 2012
Last updated: December 3, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes
Chronic Kidney Disease
Drug: Dulaglutide
Drug: Insulin glargine
Drug: Insulin lispro
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in HbA1c at 52 Weeks [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants whose HbA1c is <7.0% at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants whose HbA1c is <8.0% at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Glucose at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Mean Daily Insulin Lispro Use at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with estimated average glucose <154 mg/dL at 26 Weeks and 52 Weeks [ Time Frame: 26 Weeks and 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Serum Creatinine (SCr) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in estimated Glomerular Filtration Rate (eGFR) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in estimated Creatinine Clearance (eCrCl) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Urinary Albumin to Creatinine Ratio (UACR) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  • Hypoglycemic Episode Rate [ Time Frame: Baseline through 26 Weeks and Baseline through 52 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with Allergic/Hypersensitivity Reactions [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 564
Study Start Date: July 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dulaglutide 0.75 mg
Dulaglutide 0.75 milligram (mg) administered once weekly as a subcutaneous (SQ) injection. Participants will be instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
Drug: Dulaglutide
Administered SQ
Other Name: LY2189265
Drug: Insulin lispro
Administered SQ
Experimental: Dulaglutide 1.5 mg
Dulaglutide 1.5 mg administered once weekly as a SQ injection. Participants will be instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
Drug: Dulaglutide
Administered SQ
Other Name: LY2189265
Drug: Insulin lispro
Administered SQ
Active Comparator: Insulin glargine
Insulin glargine administered SQ to be given at bedtime per sliding scale. Participants will be instructed to administer their titrated prandial insulin lispro dose SQ with the three most significant meals of the day.
Drug: Insulin glargine
Administered SQ
Drug: Insulin lispro
Administered SQ

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621178

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Hide Study Locations
Locations
United States, Alabama
Extended Arm Physician, Inc. Active, not recruiting
Montgomery, Alabama, United States, 36106
United States, California
North American Research Institute Active, not recruiting
Azusa, California, United States, 91702
Renal Consultants Medical Group Active, not recruiting
Granada Hills, California, United States, 91344
Marin Endocrine Associates Active, not recruiting
Greenbrae, California, United States, 94904
Academic Medical Research Institute Active, not recruiting
Los Angeles, California, United States, 90022
Sutter Gould Medical Foundation Active, not recruiting
Modesto, California, United States, 95355
Infosphere Active, not recruiting
West Hills, California, United States, 91307
United States, Connecticut
Chase Medical Research, LLC Active, not recruiting
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
George Washington University Medical Center Recruiting
Washington, District of Columbia, United States, 20037
Contact    202-741-2283      
Principal Investigator: Dominic Raj         
United States, Florida
The Center for Diabetes & Endocrine Care Active, not recruiting
Hollywood, Florida, United States, 33312
East Coast Clinical Research Active, not recruiting
Jacksonville, Florida, United States, 32204
Avanced Medical and Pain Mangement Research Clinic (AMPM) Active, not recruiting
Miami, Florida, United States, 33145
Baptist Diabetes Association Active, not recruiting
Miami, Florida, United States, 33156
Pharmax Research Clinic Active, not recruiting
Miami, Florida, United States, 33126
San Marcus Research Clinic, Inc. Active, not recruiting
Miami, Florida, United States, 33015
Ocean Blue Medical Research Center, Inc. Active, not recruiting
Miami Springs, Florida, United States, 33166
Suncoast Clinical Research Active, not recruiting
New Port Richey, Florida, United States, 34652
Discovery Medical Research Group Active, not recruiting
Ocala, Florida, United States, 34471
Suncoast Clinical Research Active, not recruiting
Palm Harbor, Florida, United States, 34684
United States, Hawaii
University of Hawaii Clinical Research Active, not recruiting
Honolulu, Hawaii, United States, 96813
United States, Idaho
Boise Kidney & Hypertension Institute Active, not recruiting
Caldwell, Idaho, United States, 83605
Pacific Renal Research Institute Active, not recruiting
Meridian, Idaho, United States, 83642
United States, Kansas
Cotton O'Neil Clinic Active, not recruiting
Topeka, Kansas, United States, 66606
Univ of Kansas Schl of Medicine , Wichita Active, not recruiting
Wichita, Kansas, United States, 67214
United States, Maine
Penobscot Bay Medical Center Active, not recruiting
Rockport, Maine, United States, 04854
United States, Nebraska
Nebraska Nephrology Research Institute, LLC Active, not recruiting
Lincoln, Nebraska, United States, 68510
United States, New York
Endocrine Group, LLP Active, not recruiting
Albany, New York, United States, 12206
Erie County Medical Center State University Active, not recruiting
Buffalo, New York, United States, 14215
Institute for clinical studies Active, not recruiting
Rosedale, New York, United States, 11422
Endocrine Associates of Long Island, PC Active, not recruiting
Smithtown, New York, United States, 11787
United States, North Carolina
Carolina Clinical Trials LLC Active, not recruiting
Concord, North Carolina, United States, 28025
Physicians East Active, not recruiting
Greenville, North Carolina, United States, 27834
Diabetes & Endocrinology Consultants PC Active, not recruiting
Morehead City, North Carolina, United States, 28557
Boice Willis Clinic, PA Active, not recruiting
Rocky Mount, North Carolina, United States, 27804
United States, Pennsylvania
Thomas Jefferson University Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
Partners in Nephrology & Endocrinology Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
South Carolina Nephrology and Hypertension Center, Inc. Active, not recruiting
Orangeburg, South Carolina, United States, 29118
Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist Active, not recruiting
Sumter, South Carolina, United States, 29150
United States, Tennessee
Southeast Renal Research Institute Active, not recruiting
Chattanooga, Tennessee, United States, 37408
Knoxville Kidney Center, PLLC Active, not recruiting
Knoxville, Tennessee, United States, 37923
United States, Texas
Center For Clinical Research Active, not recruiting
Austin, Texas, United States, 78758
Endocrine Associates of Dallas Active, not recruiting
Dallas, Texas, United States, 75231
Office of Dr. Sergio Rovner Active, not recruiting
El Paso, Texas, United States, 79925
Endocrine Associates, LLC Active, not recruiting
Houston, Texas, United States, 77004
Juno Research Active, not recruiting
Houston, Texas, United States, 77036
The Endocrine Center Active, not recruiting
Houston, Texas, United States, 77079
San Antonio Kidney Disease Center Physicians Group Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Washington
Providence Health & Services Active, not recruiting
Spokane, Washington, United States, 99204
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. Active, not recruiting
Belem, Brazil, 66073-000
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Curitiba, Brazil, 80240-000
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Juiz De Fora, Brazil, 36036-330
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Passo Fundo, Brazil, 99010-080
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Porto Alegre, Brazil, 90610000
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Santa Catarina, Brazil, 89227680
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São Paulo, Brazil, 04025-011
Hungary
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Baja, Hungary, 6500
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Budapest, Hungary, 1036
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Esztergom, Hungary, 2500
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Kaposvar, Hungary, 7400
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Kecskemet, Hungary, 6000
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Pecs, Hungary, 7623
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Satoraljaujhely, Hungary, H-3980
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Siofok, Hungary, 8600
Mexico
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Chihuahua, Mexico, 31000
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Culiacan, Mexico, 80030
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Guadalajara, Mexico, 44650
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Mexico City, Mexico, 11850
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Monterrey, Mexico, 64000
Poland
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Gdansk, Poland, 80-952
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Lodz, Poland, 90302
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Szczecin, Poland, 70-111
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Zgierz, Poland, 95-100
Romania
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Bacau, Romania, 600114
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Bucharesti, Romania, 020045
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Deva, Romania, 330084
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Oradea, Romania, 410167
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Targu Mures, Romania, 540142
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Timisoara, Romania, 300125
South Africa
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Cape Town, South Africa, 7925
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Durban, South Africa, 4091
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Johannesburg, South Africa, 2198
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Somerset West, South Africa, 7130
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Worcester, South Africa, 6850
Spain
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Barcelona, Spain, 08036
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Valencia, Spain, 46026
Ukraine
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Dnipropetrovsk, Ukraine, 49005
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Kyiv, Ukraine, 2091
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Lugansk, Ukraine, 91045
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Poltava, Ukraine, 36011
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Ternopil, Ukraine, 46002
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01621178     History of Changes
Other Study ID Numbers: 13798  H9X-MC-GBDX  2012-000829-44 
Study First Received: June 14, 2012
Last Updated: December 3, 2015
Health Authority: United States: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ministry of Health
Brazil: National Health Surveillance Agency
Spain: Spanish Agency of Medicines
South Africa: Medicines Control Council
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ukraine: Ethics Committee
Ukraine: Ministry of Health
Romania: National Agency for Medicines and Medical Devices
India: Drugs Controller General of India

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Urologic Diseases
Glargine
Immunoglobulin Fc Fragments
Insulin
Insulin Lispro
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 07, 2016