Phase 3 · Dulaglutide

AWARD-6 trial results

A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (percentage of glycosylated hemoglobin), Baseline, 26 Weeks. 1.5 mg LY2189265: -1.42; 1.8 mg Liraglutide: -1.36.

Participants
599
Status
completed
Completed
2013-11
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01624259), updated at source Oct 9, 2014. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What AWARD-6 measured first

Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)percentage of glycosylated hemoglobin · Baseline, 26 Weeks · least squares mean
1.5 mg LY2189265n=2791.8 mg Liraglutiden=272
-1.42(0.05)-1.36(0.05)
Side effects by arm

Side effects in AWARD-6

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

Event1.5 mg LY21892651.8 mg Liraglutide
Any serious event1.7%3.7%
Nausea20.4%18%
Diarrhoea12%12%
Vomiting7%8.3%
Headache7.4%8.3%
Dyspepsia8%6%
Nasopharyngitis7.7%7%
Decreased appetite5.4%6.7%
Constipation3.7%5.7%
Back pain3.7%5%
Secondary outcomes

What else it measured

Change From Baseline in Body Weight at 26 Weekskilograms (kg) · Baseline, Up to 26 Weeks · least squares mean
1.5 mg LY2189265n=2991.8 mg Liraglutiden=299
-2.90(0.22)-3.61(0.22)
Change From Baseline in Body Mass Index (BMI) at 26 Weekskilograms/square meter (kg/m^2) · Baseline, Up to 26 Weeks · least squares mean
1.5 mg LY2189265n=2991.8 mg Liraglutiden=299
-1.05(0.08)-1.30(0.08)
Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeksmilligrams/deciliter (mg/dL) · Baseline, Up to 26 Weeks · least squares mean
1.5 mg LY2189265n=2811.8 mg Liraglutiden=277
-34.81(2.13)-34.25(2.11)
Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeksmg/dL · Baseline, 26 Weeks · least squares mean
1.5 mg LY2189265n=2481.8 mg Liraglutiden=256
-40.76(1.50)-38.51(1.45)
Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weekspercentage of participants · Up to 26 Weeks · number
Measure1.5 mg LY2189265n=2931.8 mg Liraglutiden=293
HbA1c levels ≤6.5%54.650.9
HbA1c levels <7.0%68.367.9
Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weekspercentage of HOMA2-%B · Baseline, Up to 26 Weeks · least squares mean
1.5 mg LY2189265n=2751.8 mg Liraglutiden=265
37.03(2.26)35.59(2.27)
Number of Participants With Reported and Adjudicated Cardiovascular Eventsparticipants · Baseline up to 26 Weeks · number
Measure1.5 mg LY2189265n=2991.8 mg Liraglutiden=300
Any reported CV events03
Any adjudicated nonfatal CV events01
Any confirmed adjudicated deaths00
Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeksbeats per minute (bpm) · Baseline, Up to 26 Weeks · least squares mean
1.5 mg LY2189265n=2731.8 mg Liraglutiden=284
1.9(0.55)4.1(0.54)
Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeksmilliseconds (msec) · Baseline, 26 Weeks · least squares mean
Measure1.5 mg LY2189265n=2731.8 mg Liraglutiden=284
PR interval (n=270, 278)3.8(0.81)3.3(0.80)
QTcF interval (n=273, 284)0.39(0.90)-0.72(0.89)
Change From Baseline in Heart Rate (HR) at 26 Weeksbpm · Baseline, 26 Weeks · least squares mean
1.5 mg LY2189265n=2881.8 mg Liraglutiden=288
2.37(0.4)3.12(0.4)
Change From Baseline in Blood Pressure (BP) at 26 Weeksmilliliters of mercury (mmHg) · Baseline, 26 Weeks · least squares mean
Measure1.5 mg LY2189265n=2781.8 mg Liraglutiden=281
Sitting DBP-0.22(0.4)-0.31(0.4)
Sitting SBP-3.36(0.7)-2.82(0.7)
Number of Participants With Adjudicated Acute Pancreatitis Eventsparticipants · Baseline up to 30 Weeks · number
1.5 mg LY2189265n=2991.8 mg Liraglutiden=300
00
The trial

How AWARD-6 was run

The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.

  • 1.5 mg LY2189265: LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks
  • Liraglutide: Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks
Who could join the trial

Inclusion Criteria: * Type 2 diabetes * Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit * Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0% * Accept continued treatment with metformin throughout the trial, as required per protocol * Men and nonpregnant women aged greater than or equal to 18 years * Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening * Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m\^2) Exclusion Criteria: * Have type 1 diabetes mellitus * Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 3 months prior to the first study visit * Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit * Have been treated with drugs that promote weight loss within 3 months of the first study visit * Are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit * Have had any of the following cardiovascular conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident * Have a known clinically significant gastric emptying abnormality (such as, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery * Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level greater than or equal to 3 times the upper limit of normal * Have a history of chronic pancreatitis or acute idiopathic pancreatitis or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit * Have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute) * Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation) * Have any self or family history of medullary C-cell...

Published papers

Papers from AWARD-6

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

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.