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 April 2014 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: April 21, 2014
Last verified: April 2014
  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: January 2016
Estimated Primary Completion Date: January 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
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Montgomery, Alabama, United States, 36106
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United States, California
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Azusa, California, United States, 91702
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Greenbrae, California, United States, 94904
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Los Angeles, California, United States, 90022
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Modesto, California, United States, 95355
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West Hills, California, United States, 91307
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United States, Connecticut
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Waterbury, Connecticut, United States, 06708
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United States, District of Columbia
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Washington, District of Columbia, United States, 20037
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United States, Florida
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32204
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Miami, Florida, United States, 33216
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Miami Springs, Florida, United States, 33166
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New Port Richey, Florida, United States, 34652
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Ocala, Florida, United States, 34471
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Palm Harbor, Florida, United States, 34684
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United States, Hawaii
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Honolulu, Hawaii, United States, 96813
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United States, Idaho
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Meridian, Idaho, United States, 83642
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United States, Kansas
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Topeka, Kansas, United States, 66606
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Wichita, Kansas, United States, 67214
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United States, Maine
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Rockport, Maine, United States, 04854
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United States, Nebraska
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Lincoln, Nebraska, United States, 68510
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Omaha, Nebraska, United States, 68131
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United States, New York
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Albany, New York, United States, 12206
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Rosedale, New York, United States, 11422
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Smithtown, New York, United States, 11787
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United States, North Carolina
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Greenville, North Carolina, United States, 27834
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Morehead City, North Carolina, United States, 28557
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Rocky Mount, North Carolina, United States, 27804
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United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15224
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United States, South Carolina
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Orangeburg, South Carolina, United States, 29118
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Sumter, South Carolina, United States, 29150
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United States, Tennessee
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Knoxville, Tennessee, United States, 37923
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United States, Texas
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Austin, Texas, United States, 78758
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77079
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San Antonio, Texas, United States, 78229
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United States, Washington
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Spokane, Washington, United States, 99220
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United States, West Virginia
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Morgantown, West Virginia, United States, 26506
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Brazil
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Belem, Brazil, 66073-000
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Belo Horizonte, Brazil, 30140-001
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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
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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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Kecskemet, Hungary, 6000
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Pecs, Hungary, 7623
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Satoraljaujhely, Hungary, H-3980
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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
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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
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Romania
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Bacau, Romania, 600114
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Bucharest, Romania, 011794
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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
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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
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Spain
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Barcelona, Spain, 08036
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Valencia, Spain, 46026
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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
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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: April 21, 2014
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
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Insulin LISPRO
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 09, 2014