Phase 3 · Dulaglutide

AWARD-9 trial results

A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine

Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) (percentage of change), Baseline, 28 Weeks. Dulaglutide + Insulin Glargine: -1.44; Placebo + Insulin Glargine: -0.67.

Participants
300
Status
completed
Completed
2015-10
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT02152371), updated at source Sep 25, 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-9 measured first

Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)percentage of change · Baseline, 28 Weeks · least squares mean
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
-1.44(0.09)-0.67(0.09)
Side effects by arm

Side effects in AWARD-9

Percent of participants affected. The most common events the registry lists.

EventDulaglutide + Insulin GlarginePlacebo + Insulin Glargine
Any serious event6%4.7%
Nausea12%1.3%
Diarrhoea11.3%4%
Nasopharyngitis4%9.3%
Upper respiratory tract infection7.3%6.7%
Decreased appetite6.7%0%
Dyspepsia6%0%
Vomiting6%0%
Secondary outcomes

What else it measured

Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)milligram per deciliter (mg/dL) · Baseline, 28 Weeks · least squares mean
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
-44.63(4.16)-27.90(4.08)
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)mg/dL · Baseline, 28 Weeks · least squares mean
MeasureDulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
Pre-Morning Meal (n=133,129)-44.03(2.71)-35.97(2.64)
Morning Meal 2-Hour Postprandial (n=123,119)-64.16(4.31)-46.97(4.27)
Pre-Midday Meal (n=133,127)-40.89(3.72)-25.34(3.62)
Midday Meal 2-Hour Post Prandial (n=123,117)-51.13(4.40)-32.98(4.33)
Pre-Evening Meal (n=133,129)-43.68(4.21)-28.71(4.07)
Evening Meal 2-Hour Postprandial (n=126,122)-48.63(5.22)-27.35(5.16)
3:00 AM (Morning) (n=124,117)-39.77(4.27)-20.30(4.23)
Change From Baseline to 28 Weeks in Body Weightkilogram(kg) · Baseline, 28 Weeks · least squares mean
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
-1.91(0.30)0.50(0.30)
Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Doseunits (u) · Baseline, 28 Weeks · least squares mean
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
12.75(2.27)25.94(2.30)
Number of Participants With Investigator Reported and Adjudicated Cardiovascular Eventsparticipants · Baseline through 28 Weeks · number
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
31
Percentage of Participants With Self-Reported Events of Hypoglycemiapercentage of participants · Baseline through 28 Weeks · number
MeasureDulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
Symptomatic35.330.0
Asymptomatic42.739.3
Severe0.70.0
Nocturnal28.028.7
Probable Symptomatic2.72.0
Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemiapercentage of participants · Baseline through 28 Weeks · number
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
00
Number of Participants With Adjudicated Acute Pancreatitis Eventsparticipants · Baseline through 28 Weeks · number
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
00
Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)participants · Baseline through 28 Weeks · number
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
10
Number of Participants With Dulaglutide Anti-Drug Antibodiesparticipants · Baseline, Week 12 and Week 28 · number
Dulaglutide + Insulin Glarginen=149Placebo + Insulin Glarginen=149
02
Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%percentage of participants · 28 Weeks · number
MeasureDulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
HbA1c <= 6.550.716.7
HbA1c < 7.069.335.3
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)percentage of participants · 28 Weeks · number
Dulaglutide + Insulin Glarginen=150Placebo + Insulin Glarginen=150
40.716.7
The trial

How AWARD-9 was run

The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine. The study will last about 31 weeks for each participant.

  • Dulaglutide + Insulin Glargine: 1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
  • Placebo + Insulin Glargine: Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Who could join the trial

Inclusion Criteria: * Have type 2 diabetes (based on the World Health Organization's \[WHO\] diagnostic criteria) * Have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening * Doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (≥1500 mg/day) and the maximum approved dose per the locally-approved label * Have an HbA1c value ≥7.0% and ≤10.5% as assessed by the central laboratory at screening * Require further insulin glargine dose increase at week 3 per the treat-to-target (TTT) algorithm based on the SMPG data collected during the prior week * Have stable weight (±5%) ≥3 months prior to screening * Have body mass index (BMI) ≤45 kilograms per square meter (kg/m\^2) at screening * Are able and willing to administer once weekly randomized therapy * Are females of childbearing potential who must: * Test negative for pregnancy at screening, based on a serum pregnancy test * Agree to use a reliable method of birth control * Not be breastfeeding Exclusion Criteria: * Have been treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with or without metformin, within the 3 months prior to screening or between screening and week 3 * Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma * Have a history of hypoglycemia unawareness within the 6 months prior to screening * Have been treated with drugs that promote weight loss within the 3 months prior to screening or between screening and week 3 * Are receiving chronic (\>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks prior to screening or between screening and week 3 * Have had any of the following cardiovascular conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke) * Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery * Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory * Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening * Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter (mL/min/m\^2), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory; for participants on metformin, have renal disease or renal dysfunction (for example, a serum...

Published papers

Papers from AWARD-9

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

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