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AzTrials

Type 2 DiabetesPhase 3AWARD-7NCT01621178

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)

A Phase 3 study testing Dulaglutide, Insulin glargine and Insulin lispro in people with Type 2 Diabetes and Chronic Kidney Disease, run by Eli Lilly and Company at 89 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Chronic Kidney Disease
What is being tested?
Dulaglutide, Insulin glargine and Insulin lispro
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
577 participants
Where
89 sitesin 9 countries
Study dates
Jul 2012to Dec 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

89 sites in 9 countries.

89 sites in 9 countries

United States47 sites

  • Endocrine Group, LLP

    Albany, New York, 12206

  • Center For Clinical Research

    Austin, Texas, 78758

  • North American Research Institute

    Azusa, California, 91702

  • Erie County Medical Center State University

    Buffalo, New York, 14215

  • Boise Kidney & Hypertension Institute

    Caldwell, Idaho, 83605

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37408

  • Carolina Clinical Trials LLC

    Concord, North Carolina, 28025

  • Endocrine Associates of Dallas

    Dallas, Texas, 75231

  • Office of Dr. Sergio Rovner

    El Paso, Texas, 79925

  • Renal Consultants Medical Group

    Granada Hills, California, 91344

  • Marin Endocrine Associates

    Greenbrae, California, 94904

  • Physicians East

    Greenville, North Carolina, 27834

  • The Center for Diabetes & Endocrine Care

    Hollywood, Florida, 33312

  • University of Hawaii Clinical Research

    Honolulu, Hawaii, 96813

  • Endocrine Associates, LLC

    Houston, Texas, 77004

  • Juno Research

    Houston, Texas, 77036

  • The Endocrine Center

    Houston, Texas, 77079

  • East Coast Clinical Research

    Jacksonville, Florida, 32204

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923

  • Nebraska Nephrology Research Institute, LLC

    Lincoln, Nebraska, 68510

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Pacific Renal Research Institute

    Meridian, Idaho, 83642

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33015

  • Pharmax Research Clinic

    Miami, Florida, 33126

  • Avanced Medical and Pain Mangement Research Clinic (AMPM)

    Miami, Florida, 33145

  • Baptist Diabetes Association

    Miami, Florida, 33156

  • Ocean Blue Medical Research Center, Inc.

    Miami Springs, Florida, 33166

  • Sutter Gould Medical Foundation

    Modesto, California, 95355

  • Extended Arm Physician, Inc.

    Montgomery, Alabama, 36106

  • Diabetes & Endocrinology Consultants PC

    Morehead City, North Carolina, 28557

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Discovery Medical Research Group

    Ocala, Florida, 34471

  • South Carolina Nephrology and Hypertension Center, Inc.

    Orangeburg, South Carolina, 29118

  • Suncoast Clinical Research

    Palm Harbor, Florida, 34684

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Partners in Nephrology & Endocrinology

    Pittsburgh, Pennsylvania, 15224

  • Penobscot Bay Medical Center

    Rockport, Maine, 04854

  • Boice Willis Clinic, PA

    Rocky Mount, North Carolina, 27804

  • Institute for clinical studies

    Rosedale, New York, 11422

  • San Antonio Kidney Disease Center Physicians Group

    San Antonio, Texas, 78229

  • Endocrine Associates of Long Island, PC

    Smithtown, New York, 11787

  • Providence Health & Services

    Spokane, Washington, 99204

  • Carolina Diabetes & Kidney Ctr. Sumter Medical Specialist

    Sumter, South Carolina, 29150

  • Cotton O'Neil Clinic

    Topeka, Kansas, 66606

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Infosphere

    West Hills, California, 91307

  • Univ of Kansas Schl of Medicine , Wichita

    Wichita, Kansas, 67214

Other trials in United States

Hungary8 sites

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in Hungary

Brazil7 sites

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in Brazil

Romania6 sites

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in Romania

Mexico5 sites

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in Mexico

South Africa5 sites

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in South Africa

Ukraine5 sites

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in Ukraine

Poland4 sites

  • 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

  • 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

  • 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

  • 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

Other trials in Poland

Spain2 sites

  • 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

  • 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

Other trials in Spain

About this study

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

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.

Being tested
Dulaglutide, Insulin glargine, Insulin lispro
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DulaglutideDrug

    Also called LY2189265

    Administered SC

  • Insulin glargineDrug

    Administered SC

  • Insulin lisproDrug

    Administered SC

Study groups in NCT01621178
Study groupRoleWhat they receive
Insulin glargineActive 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.
Receives: Drug: Insulin glargine; Drug: Insulin lispro
0.75 mg DulaglutideExperimental0.75 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.
Receives: Drug: Dulaglutide; Drug: Insulin lispro
1.5 mg DulaglutideExperimental1.5 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.
Receives: Drug: Dulaglutide; Drug: Insulin lispro

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 26 Weeks

Secondary outcomes (28)

  1. Percentage of Participants Whose HbA1c Was <7.0%

    Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).

    Measured: 26 Weeks

  2. Percentage of Participants Whose HbA1c Was <8.0%

    Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).

    Measured: 26 Weeks

  3. Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)

    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).

    Measured: Baseline, 26 Weeks

  4. Change From Baseline in Fasting Glucose (FG)

    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

    Measured: Baseline, 26 Weeks

  5. Change From Baseline in Mean Daily Insulin Lispro Dose

    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 mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.

    Measured: Baseline, 26 Weeks

  6. Percentage of Participants With Estimated Average Glucose <154 mg/dL

    Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).

    Measured: 26 Weeks

  7. Change From Baseline in Serum Creatinine (sCr)

    Change from baseline in serum creatinine (sCr) levels after treatment.

    Measured: Baseline, 26 Weeks

  8. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

    The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.

    Measured: Baseline, 26 Weeks

  9. Change From Baseline in Estimated Creatinine Clearance (eCrCl)

    Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.

    Measured: Baseline, 26 Weeks

  10. Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)

    The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).

    Measured: Baseline, 26 Weeks

  11. Change From Baseline in Body Weight

    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.

    •

    Measured: Baseline, 26 Weeks

  12. Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

    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.

    Measured: Baseline through 26 Weeks

  13. Rate of Hypoglycemic Events

    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.

    Measured: Baseline through 26 Weeks

  14. Change From Baseline in HbA1c

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c 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 CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.

    Measured: Baseline, 52 Weeks

  15. Percentage of Participants Whose HbA1c is <7.0%

    Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).

    Measured: 52 Weeks

  16. Percentage of Participants Whose HbA1c is <8.0%

    Percentage of participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).

    Measured: 52 Weeks

  17. Change From Baseline in 8-Point SMPG

    The daily mean of 8-point SMPG profile at Week 52 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).

    Measured: Baseline, 52 Weeks

  18. Change From Baseline in FG

    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

    Measured: Baseline, 52 Weeks

  19. Change in Mean Daily Insulin Lispro Dose

    The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.

    Measured: Baseline, 52 Weeks

  20. Percentage of Participants With Estimated Average Glucose <154 mg/dL

    Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).

    Measured: 52 Weeks

  21. Change From Baseline in sCr

    Change from baseline in sCr levels after treatment.

    Measured: Baseline, 52 Weeks

  22. Change From Baseline in eGFR

    The change in eGFR by using CKD-EPI equation.

    Measured: Baseline, 52 Weeks

  23. Change From Baseline in eCrCl

    eCrCl was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.

    Measured: Baseline, 52 Weeks

  24. Change From Baseline in UACR

    The change from baseline in UACR

    Measured: Baseline, 52 Weeks

  25. Change From Baseline in Body Weight

    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.

    Measured: Baseline, 52 Weeks

  26. Percentage of Participants With Self-Reported Hypoglycemic Events (HE)

    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 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

    Measured: Baseline through 52 Weeks

  27. Rate of Hypoglycemic Events (HE)

    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 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

    Measured: Baseline through 52 Weeks

  28. Participants With Events of Allergic/Hypersensitivity Reactions

    Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ

    Measured: Baseline through 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJun 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
577 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01621178
Sponsor's protocol ID
13798
Other IDs
H9X-MC-GBDX, 2012-000829-44
Acronym
AWARD-7
Status last verified
Sep 2019
First submitted
14 Jun 2012
Last updated
19 Sep 2019
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39963952

  • Tuttle 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.

    PubMed 29910024

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dulaglutide, Insulin glargine and Insulin lispro in people with Type 2 Diabetes and Chronic Kidney Disease, run by Eli Lilly and Company at 89 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Hungary, Brazil, Romania, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, 26 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01621178, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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