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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01621178
First received: June 14, 2012
Last updated: February 25, 2016
Last verified: February 2016
  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 ]

Enrollment: 576
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 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   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, Alabama
Extended Arm Physician, Inc.
Montgomery, Alabama, United States, 36106
United States, California
North American Research Institute
Azusa, California, United States, 91702
Renal Consultants Medical Group
Granada Hills, California, United States, 91344
Marin Endocrine Associates
Greenbrae, California, United States, 94904
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Sutter Gould Medical Foundation
Modesto, California, United States, 95355
Infosphere
West Hills, California, United States, 91307
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
The Center for Diabetes & Endocrine Care
Hollywood, Florida, United States, 33312
East Coast Clinical Research
Jacksonville, Florida, United States, 32204
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, United States, 33166
San Marcus Research Clinic, Inc.
Miami, Florida, United States, 33015
Pharmax Research Clinic
Miami, Florida, United States, 33126
Avanced Medical and Pain Mangement Research Clinic (AMPM)
Miami, Florida, United States, 33145
Baptist Diabetes Association
Miami, Florida, United States, 33156
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
Discovery Medical Research Group
Ocala, Florida, United States, 34471
Suncoast Clinical Research
Palm Harbor, Florida, United States, 34684
United States, Hawaii
University of Hawaii Clinical Research
Honolulu, Hawaii, United States, 96813
United States, Idaho
Boise Kidney & Hypertension Institute
Caldwell, Idaho, United States, 83605
Pacific Renal Research Institute
Meridian, Idaho, United States, 83642
United States, Kansas
Cotton O'Neil Clinic
Topeka, Kansas, United States, 66606
Univ of Kansas Schl of Medicine , Wichita
Wichita, Kansas, United States, 67214
United States, Maine
Penobscot Bay Medical Center
Rockport, Maine, United States, 04854
United States, Nebraska
Nebraska Nephrology Research Institute, LLC
Lincoln, Nebraska, United States, 68510
United States, New York
Endocrine Group, LLP
Albany, New York, United States, 12206
Erie County Medical Center State University
Buffalo, New York, United States, 14215
Institute for clinical studies
Rosedale, New York, United States, 11422
Endocrine Associates of Long Island, PC
Smithtown, New York, United States, 11787
United States, North Carolina
Carolina Clinical Trials LLC
Concord, North Carolina, United States, 28025
Physicians East
Greenville, North Carolina, United States, 27834
Diabetes & Endocrinology Consultants PC
Morehead City, North Carolina, United States, 28557
Boice Willis Clinic, PA
Rocky Mount, North Carolina, United States, 27804
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Partners in Nephrology & Endocrinology
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
South Carolina Nephrology and Hypertension Center, Inc.
Orangeburg, South Carolina, United States, 29118
Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist
Sumter, South Carolina, United States, 29150
United States, Tennessee
Southeast Renal Research Institute
Chattanooga, Tennessee, United States, 37408
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States, 37923
United States, Texas
Center For Clinical Research
Austin, Texas, United States, 78758
Endocrine Associates of Dallas
Dallas, Texas, United States, 75231
Office of Dr. Sergio Rovner
El Paso, Texas, United States, 79925
Endocrine Associates, LLC
Houston, Texas, United States, 77004
Juno Research
Houston, Texas, United States, 77036
The Endocrine Center
Houston, Texas, United States, 77079
San Antonio Kidney Disease Center Physicians Group
San Antonio, Texas, United States, 78229
United States, Washington
Providence Health & Services
Spokane, Washington, United States, 99204
Brazil
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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

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: February 25, 2016
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
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Insulin, Globin Zinc
Dulaglutide
Insulin
Insulin Glargine
Insulin Lispro
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors

ClinicalTrials.gov processed this record on August 24, 2016