Phase 3 · Dulaglutide

AWARD-8 trial results

A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8)

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks (percent change of HbA1c), Baseline, 24 Weeks. Dulaglutide: -1.38; Placebo: -0.11.

Participants
300
Status
completed
Completed
2014-12
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01769378), updated at source Jan 25, 2016. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What AWARD-8 measured first

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weekspercent change of HbA1c · Baseline, 24 Weeks · least squares mean
Dulaglutiden=215Placebon=53
-1.38(0.08)-0.11(0.14)
Side effects by arm

Side effects in AWARD-8

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

EventDulaglutidePlacebo
Any serious event3.8%0%
Nausea10.5%0%
Diarrhoea8.4%0%
Eructation5.9%0%
Hyperglycemia0.4%5%
Secondary outcomes

What else it measured

Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weekspercentage of participants · 24 Weeks · number
MeasureDulaglutiden=215Placebon=53
Percent Achieved <7.0 HbA1c Level55.318.9
Percent Achieved ≤6.5 HbA1c Level40.09.4
Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeksmilligrams per deciliter (mg/dL) · Baseline, 24 Weeks · least squares mean
Dulaglutiden=218Placebon=51
-30.60(4.46)2.93(6.76)
Change From Baseline in Body Weight at 24 Weekskilograms (kg) · Baseline, 24 Weeks · least squares mean
Dulaglutiden=212Placebon=53
-0.91(0.21)-0.24(0.40)
Change From Baseline in Body Mass Index (BMI) at 24 Weekskilograms per/square meter kg/m^2 · Baseline, 24 Weeks · least squares mean
Dulaglutiden=212Placebon=53
-0.32(0.08)-0.10(0.15)
Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeksmg/dL · Baseline, 24 Weeks · least squares mean
Dulaglutiden=203Placebon=49
-37.22(3.10)-8.27(4.77)
Number of Participants With Reported and Adjudicated Cardiovascular Eventsparticipants · Baseline through 24 Weeks, 30-day Follow Up · number
MeasureDulaglutiden=239Placebon=60
Any reported CV events20
Any adjudicated nonfatal CV events20
Any confirmed adjudicated CV deaths00
Number of Participants With Adjudicated Acute Pancreatitis Eventsparticipants · Baseline through 24 Weeks, 30-day Follow Up · number
Dulaglutiden=239Placebon=60
00
Change From Baseline in Calcitonin at 24 Weekspicogram per milliliter (pg/ml) · Baseline, 24 Weeks · median
Dulaglutiden=215Placebon=59
0.00(0.00 to 0.00)0.00(0.00 to 0.00)
Percentage of Participants With Self-Reported Events of Hypoglycemiapercentage of participants · Baseline through 24 Weeks · number
MeasureDulaglutiden=239Placebon=60
Symptomatic11.31.7
Asymptomatic13.41.7
Probable2.50.0
Severe00
Nocturnal6.71.7
Rate of HE Adjusted Per 30 Daysnumber of events/participants/30 days · Baseline through 24 weeks · mean
MeasureDulaglutiden=239Placebon=60
Total HE0.19(0.59)0.01(0.03)
Documented symptomatic HE0.07(0.33)0.00(0.02)
Asymptomatic HE0.11(0.45)0.00(0.02)
Severe HE0(0.0)0(0.0)
Nocturnal HE0.02(0.16)0.00(0.02)
Probable symptomatic HE0.01(0.04)0(0.0)
Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemiapercentage of participants · Baseline through 24 Weeks · number
Dulaglutiden=239Placebon=60
2.111.7
Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemiaweeks · Baseline through 24 Weeks · mean
Dulaglutiden=239Placebon=60
22.59(0.36)22.47(0.66)
The trial

How AWARD-8 was run

The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.

  • Placebo: Placebo administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
  • Dulaglutide: Dulaglutide 1.5 milligram (mg) administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Who could join the trial

Inclusion Criteria: * Type 2 diabetes mellitus * Stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit * Have an HbA1c value of ≥7.5% and ≤9.5%, as determined by the central laboratory draw performed at the first study visit * Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol * Men and nonpregnant women aged ≥18 years * Stable weight (±5%) ≥3 months prior to screening * Body Mass Index (BMI) ≤45 kilograms per square meter (kg/m\^2) Exclusion Criteria: * Have type 1 diabetes mellitus * Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 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 within 3 months prior to the first study visit is exclusionary * Have been treated with drugs that promote weight loss within 3 months prior to the first study visit * Are receiving chronic (\>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 (CV) 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 (eg, 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 \>2.5 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 an estimated glomerular filtration rate \[eGFR\] \<30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2), calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation as determined by the central laboratory at the first study visit * Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) 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 hyperplasia, focal hyperplasia,...

Published papers

Papers from AWARD-8

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

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