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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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)

Short name AWARD-7

NCTNCT01621178 (opens ClinicalTrials.gov in a new tab)Other id13798Other idH9X-MC-GBDXOther id2012-000829-44
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
577 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
9 countries

United States, Brazil, Hungary, Mexico, Poland, Romania, South Africa, Spain, Ukraine

Start
Jul 2012
Primary completion
Jun 2016
Completion
Dec 2016
First posted
18 Jun 2012 (estimated)
Last update posted
19 Sept 2019
Conditions
Type 2 Diabetes · Chronic Kidney Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014201520162017
  1. Ph 3

    AWARD-7

    NCT01621178

    Jul 2012 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DulaglutideDrug
  • Insulin glargineDrug
  • Insulin lisproDrug

Arms3

  • Active comparator

    Insulin glargine

    Insulin 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.

  • Experimental

    0.75 mg Dulaglutide

    0.75 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.

  • Experimental

    1.5 mg Dulaglutide

    1.5 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, 26 Weeks

    Registry description

    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 outcomes(20)

  1. Percentage of Participants Whose HbA1c Was <7.0%

    Time frame · 26 Weeks

    Registry description

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

  2. Percentage of Participants Whose HbA1c Was <8.0%

    Time frame · 26 Weeks

    Registry description

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

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

    Time frame · Baseline, 26 Weeks

    Registry description

    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).

  4. Change From Baseline in Fasting Glucose (FG)

    Time frame · Baseline, 26 Weeks

    Registry description

    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

  5. Change From Baseline in Mean Daily Insulin Lispro Dose

    Time frame · Baseline, 26 Weeks

    Registry description

    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.

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

    Time frame · 26 Weeks

    Registry description

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

  7. Change From Baseline in Serum Creatinine (sCr)

    Time frame · Baseline, 26 Weeks

    Registry description

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

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

    Time frame · Baseline, 26 Weeks

    Registry description

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

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

    Time frame · Baseline, 26 Weeks

    Registry description

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

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

    Time frame · Baseline, 26 Weeks

    Registry description

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

  11. Change From Baseline in Body Weight

    Time frame · Baseline, 26 Weeks

    Registry description

    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. •

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

    Time frame · Baseline through 26 Weeks

    Registry description

    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.

  13. Rate of Hypoglycemic Events

    Time frame · Baseline through 26 Weeks

    Registry description

    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.

  14. Change From Baseline in HbA1c

    Time frame · Baseline, 52 Weeks

    Registry description

    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.

  15. Percentage of Participants Whose HbA1c is <7.0%

    Time frame · 52 Weeks

    Registry description

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

  16. Percentage of Participants Whose HbA1c is <8.0%

    Time frame · 52 Weeks

    Registry description

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

  17. Change From Baseline in 8-Point SMPG

    Time frame · Baseline, 52 Weeks

    Registry description

    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).

  18. Change From Baseline in FG

    Time frame · Baseline, 52 Weeks

    Registry description

    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

  19. Change in Mean Daily Insulin Lispro Dose

    Time frame · Baseline, 52 Weeks

    Registry description

    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.

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

    Time frame · 52 Weeks

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, 26 Weeks

Change From Baseline in Hemoglobin A1c (HbA1c)

GroupValue (percentage of HbA1c)Spread
Insulin Glargine-1.130.12
Dulaglutide 0.75 mg-1.120.12
Dulaglutide 1.5 mg-1.190.13
Secondary and other outcome results(7)
Secondary outcomeNumber· 26 Weeks

Percentage of Participants Whose HbA1c Was <7.0%

GroupValue (percentage of participants)
Insulin Glargine34.6
Dulaglutide 0.75 mg31.7
Dulaglutide 1.5 mg37.5
Secondary outcomeNumber· 26 Weeks

Percentage of Participants Whose HbA1c Was <8.0%

GroupValue (percentage of participants)
Insulin Glargine75.3
Dulaglutide 0.75 mg72.6
Dulaglutide 1.5 mg78.3
Secondary outcomeLeast squares mean· Baseline, 26 Weeks

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

GroupValue (milligrams/deciliter (mg/dL))Spread
Insulin Glargine-37.63.41
Dulaglutide 0.75 mg-31.73.53
Dulaglutide 1.5 mg-33.73.77
Secondary outcomeLeast squares mean· Baseline, 26 Weeks

Change From Baseline in Fasting Glucose (FG)

GroupValue (milligram/deciliter (mg/dL))Spread
Insulin Glargine-19.16.00
Dulaglutide 0.75 mg17.76.14
Dulaglutide 1.5 mg23.16.50
Secondary outcomeLeast squares mean· Baseline, 26 Weeks

Change From Baseline in Mean Daily Insulin Lispro Dose

GroupValue (Units/day (U/day))Spread
Insulin Glargine16.642.76
Dulaglutide 0.75 mg26.162.80
Dulaglutide 1.5 mg18.123.00
Secondary outcomeNumber· 26 Weeks

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

GroupValue (percentage of participants)
Insulin Glargine64.9
Dulaglutide 0.75 mg52.5
Dulaglutide 1.5 mg56.4
Secondary outcomeMedian· Baseline, 26 Weeks

Change From Baseline in Serum Creatinine (sCr)

GroupValue (mg/dL)
Insulin Glargine0.10
Dulaglutide 0.75 mg0.02
Dulaglutide 1.5 mg0.04

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Insulin GlargineInsulin glargine administered SC to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day.–56 / 194130 / 194
Dulaglutide 0.75 mgDulaglutide 0.75 mg 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.–48 / 190134 / 190
Dulaglutide 1.5 mgDulaglutide 1.5 mg 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.–41 / 192144 / 192

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Randomized controlled trial · 2018

17 results

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.

Tuttle et al. 2018The lancet. Diabetes & endocrinologycited by 506

PMID 29910024DOI 10.1016/s2213-8587(18)30104-9PUB-29910024

Full text at the publisher17 results
Publisher pageSee results (17)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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