Phase 3 · Dulaglutide

AWARD-7 trial results

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

Change From Baseline in Hemoglobin A1c (HbA1c) (percentage of HbA1c), Baseline, 26 Weeks. Insulin Glargine: -1.13; Dulaglutide 0.75 mg: -1.12; Dulaglutide 1.5 mg: -1.19.

Participants
577
Status
completed
Completed
2016-12
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01621178), updated at source Sep 19, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What AWARD-7 measured first

Change From Baseline in Hemoglobin A1c (HbA1c)percentage of HbA1c · Baseline, 26 Weeks · least squares mean
Insulin Glarginen=175Dulaglutide 0.75 mgn=149Dulaglutide 1.5 mgn=138
-1.13(0.12)-1.12(0.12)-1.19(0.13)
Side effects by arm

Side effects in AWARD-7

Percent of participants affected, Up To Week 52. The most common events the registry lists.

EventInsulin GlargineDulaglutide 0.75 mgDulaglutide 1.5 mg
Any serious event28.9%25.3%21.4%
Blood creatinine increased46.4%37.4%38.5%
Nausea4.6%14.2%19.8%
Diarrhoea7.2%15.8%16.1%
Vomiting4.6%8.4%13.5%
Glomerular filtration rate decreased13.4%10.5%8.9%
Upper respiratory tract infection10.3%6.8%4.2%
Hypertension10.3%6.8%7.3%
Urinary tract infection9.8%5.3%6.8%
Weight increased8.2%4.7%4.7%
Influenza5.2%7.9%6.3%
Oedema peripheral7.7%6.3%5.2%
Cough7.7%3.7%3.6%
Hyperkalaemia6.7%4.2%6.3%
Constipation3.1%5.3%6.3%
Nasopharyngitis6.2%4.7%5.7%
Dizziness5.2%5.8%4.2%
Sinusitis5.7%2.1%1%
Decreased appetite1.5%2.6%5.7%
Anaemia5.2%1.6%2.6%
Back pain3.6%4.2%5.2%
Secondary outcomes

What else it measured

Percentage of Participants Whose HbA1c Was <7.0%percentage of participants · 26 Weeks · number
Insulin Glarginen=182Dulaglutide 0.75 mgn=164Dulaglutide 1.5 mgn=152
34.631.737.5
Percentage of Participants Whose HbA1c Was <8.0%percentage of participants · 26 Weeks · number
Insulin Glarginen=182Dulaglutide 0.75 mgn=164Dulaglutide 1.5 mgn=152
75.372.678.3
Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)milligrams/deciliter (mg/dL) · Baseline, 26 Weeks · least squares mean
Insulin Glarginen=128Dulaglutide 0.75 mgn=107Dulaglutide 1.5 mgn=102
-37.6(3.41)-31.7(3.53)-33.7(3.77)
Change From Baseline in Fasting Glucose (FG)milligram/deciliter (mg/dL) · Baseline, 26 Weeks · least squares mean
Insulin Glarginen=162Dulaglutide 0.75 mgn=145Dulaglutide 1.5 mgn=132
-19.1(6.00)17.7(6.14)23.1(6.50)
Change From Baseline in Mean Daily Insulin Lispro DoseUnits/day (U/day) · Baseline, 26 Weeks · least squares mean
Insulin Glarginen=177Dulaglutide 0.75 mgn=154Dulaglutide 1.5 mgn=141
16.64(2.76)26.16(2.80)18.12(3.00)
Percentage of Participants With Estimated Average Glucose <154 mg/dLpercentage of participants · 26 Weeks · number
Insulin Glarginen=134Dulaglutide 0.75 mgn=118Dulaglutide 1.5 mgn=110
64.952.556.4
Change From Baseline in Serum Creatinine (sCr)mg/dL · Baseline, 26 Weeks · median
Insulin Glarginen=176Dulaglutide 0.75 mgn=169Dulaglutide 1.5 mgn=163
0.10(-0.04 to 0.28)0.02(-0.15 to 0.15)0.04(-0.14 to 0.20)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)milliliter/minute/1.73m2 (mL/min/1.73m2) · Baseline, 26 Weeks · median
Insulin Glarginen=176Dulaglutide 0.75 mgn=169Dulaglutide 1.5 mgn=163
-2.5(-6.0 to 1.0)-1.0(-4.5 to 3.0)-1.0(-5.5 to 3.0)
Change From Baseline in Estimated Creatinine Clearance (eCrCl)milliliter/minute (ml/min) · Baseline, 26 Weeks · median
Insulin Glarginen=176Dulaglutide 0.75 mgn=169Dulaglutide 1.5 mgn=163
-2.0(-4.0 to 0.5)-1.0(-3.5 to 2.0)-0.5(-4.0 to 2.0)
Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)gram/kilogram (g/kg) · Baseline, 26 Weeks · median
Insulin Glarginen=181Dulaglutide 0.75 mgn=175Dulaglutide 1.5 mgn=175
-1.3(-71.7 to 62.0)-11.1(-147.8 to 33.2)-10.2(-180.5 to 53.1)
Change From Baseline in Body Weightkilogram (kg) · Baseline, 26 Weeks · least squares mean
Insulin Glarginen=175Dulaglutide 0.75 mgn=151Dulaglutide 1.5 mgn=140
1.11(0.346)-2.02(0.357)-2.81(0.374)
Percentage of Participants With Self-Reported Hypoglycemic Events (HE)percentage of participants · Baseline through 26 Weeks · number
MeasureInsulin Glarginen=194Dulaglutide 0.75 mgn=189Dulaglutide 1.5 mgn=190
Total Hypo71.650.843.2
Documented Symptomatic Hypo60.340.731.6
Severe Hypo4.11.10
Nocturnal Hypo38.115.913.2
The trial

How AWARD-7 was run

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.

  • 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.
  • 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.
  • 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.
Who could join the trial

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

Published papers

Papers from AWARD-7

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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