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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01621178
First received: June 14, 2012
Last updated: June 21, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
Masking Description:
Dulaglutide dose was blinded to participant, care provider, investigator and outcomes assessor.
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) [ Time Frame: Baseline, 26 Weeks ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Whose HbA1c Was <7.0% [ Time Frame: 26 Weeks ]
    Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).

  • Percentage of Participants Whose HbA1c Was <8.0% [ Time Frame: 26 Weeks ]
    Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).

  • Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) [ Time Frame: Baseline, 26 Weeks ]
    The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime).

  • Change From Baseline in Fasting Glucose (FG) [ Time Frame: Baseline, 26 Weeks ]
    LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured

  • Change From Baseline in Mean Daily Insulin Lispro Dose [ Time Frame: 26 Weeks ]
    The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.

  • Percentage of Participants With Estimated Average Glucose <154 mg/dL [ Time Frame: 26 Weeks ]
    Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).

  • Change From Baseline in Serum Creatinine (sCr) [ Time Frame: Baseline, 26 Weeks ]
    Change from baseline in serum creatinine (sCr) levels after treatment.

  • Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline, 26 Weeks ]
    The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.

  • Change From Baseline in Estimated Creatinine Clearance (eCrCl) [ Time Frame: Baseline, 26 Weeks ]
    eEstimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.

  • Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline, 26 Weeks ]
    The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).

  • Change From Baseline in Body Weight [ Time Frame: Baseline, 26 Weeks ]
    LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.

  • Percentage of Participants With Self-Reported Hypoglycemic Events (HE) [ Time Frame: Baseline through 26 Weeks ]
    Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

  • Rate of Hypoglycemic Events [ Time Frame: Baseline through 26 Weeks ]
    Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

  • Change From Baseline in HbA1c [ Time Frame: Baseline, 52 Weeks ]
  • Percentage of Participants Whose HbA1c is <7.0% [ Time Frame: 52 Weeks ]
  • Percentage of Participants Whose HbA1c is <8.0% [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Fasting Glucose [ Time Frame: Baseline, 52 Weeks ]
  • Change in Mean Daily Insulin Lispro Dose [ Time Frame: Baseline, 52 Weeks ]
  • Percentage of Participants With Estimated Average Glucose <154 mg/dL [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Serum Creatinine (sCr) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Estimated Creatinine Clearance (eCrCl) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline, 52 Weeks ]
  • Change From Baseline in Body Weight [ Time Frame: Baseline, 52 Weeks ]
  • Percentage of Participants With Self-Reported HE [ Time Frame: Baseline, 52 Weeks ]
  • Rate of HE [ Time Frame: Baseline, 52 Weeks ]
  • Percentage of Participants With Allergic/Hypersensitivity Reactions [ Time Frame: Baseline through 52 Weeks ]

Enrollment: 577
Study Start Date: July 2012
Study Completion Date: December 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin glargine
Insulin glargine was administered SQ at bedtime per a modified forced-titration treat-to-target algorithm. Participants were 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
Experimental: 0.75 mg Dulaglutide
0.75 milligram (mg) of dulaglutide was administered once weekly as a subcutaneous (SQ) injection. Participants were 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: 1.5 mg Dulaglutide
1.5 mg of dulaglutide was administered once weekly as a SQ injection. Participants were 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 ( Other Identifier: Eli Lilly and Company )
2012-000829-44 ( EudraCT Number )
Study First Received: June 14, 2012
Results First Received: June 21, 2017
Last Updated: June 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual participant data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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 16, 2017