Phase 3 · Dulaglutide

AWARD-11 trial results

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus

Change in Hemoglobin A1c (HbA1c) From Baseline (Percentage of HbA1c), Baseline, Week 36. Dulaglutide 1.5 mg: -1.53; Dulaglutide 3 mg: -1.71; Dulaglutide 4.5 mg: -1.87.

Participants: 1,842
Status: completed
Completed: 2019-10-10
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT03495102), updated at source Jun 12, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What AWARD-11 measured first

Change in Hemoglobin A1c (HbA1c) From BaselinePercentage of HbA1c · Baseline, Week 36 · least squares mean

Dulaglutide 1.5 mgn=523	Dulaglutide 3 mgn=521	Dulaglutide 4.5 mgn=526
-1.53(0.04)	-1.71(0.04)	-1.87(0.04)

Side effects by arm

Side effects in AWARD-11

Percent of participants affected, Up to Week 56. The most common events the registry lists.

Event	Dulaglutide 1.5 mg	Dulaglutide 3 mg	Dulaglutide 4.5 mg
Any serious event	8.7%	7.3%	6.2%
Nausea	14.2%	16.1%	17.3%
Diarrhoea	7.8%	12.2%	11.4%
Vomiting	6.5%	9.3%	10.4%
Nasopharyngitis	4.7%	5.4%	6.4%
Dyspepsia	2.8%	5.4%	2.9%

Secondary outcomes

What else it measured

Change in Body Weight From BaselineKilograms (Kg) · Baseline, Week 36 · least squares mean

Dulaglutide 1.5 mgn=522	Dulaglutide 3 mgn=520	Dulaglutide 4.5 mgn=526
-3.1(0.19)	-4.0(0.19)	-4.7(0.19)

Percentage of Participants Achieving HbA1c Target <7.0%percentage of participants · Week 36 · number

Dulaglutide 1.5 mgn=523	Dulaglutide 3 mgn=521	Dulaglutide 4.5 mgn=526
56.98	64.68	71.48

Change in Fasting Serum Glucose (FSG) From Baselinemilligrams per deciliter (mg/dL) · Baseline, Week 36 · least squares mean

Dulaglutide 1.5 mgn=510	Dulaglutide 3 mgn=509	Dulaglutide 4.5 mgn=514
-44.2(1.50)	-47.9(1.50)	-52.3(1.50)

Rate of Documented Symptomatic Hypoglycemic EpisodesEpisodes/participant/365.25 days · Week 36 · mean

Dulaglutide 1.5 mgn=612	Dulaglutide 3 mgn=616	Dulaglutide 4.5 mgn=614
0.02(0.01)	0.00(0.00)	0.02(0.01)

Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)nanogram/milliliter (ng/mL) · Week 4, Week 12, Week 36, Week 52 · mean

Dulaglutide 1.5 mgn=612	Dulaglutide 3 mgn=616	Dulaglutide 4.5 mgn=614
79.6(77.7 to 81.7)	159(155 to 163)	238(232 to 243)

Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady Statenanogram*hour/milliliter (ng*h/mL) · Week 4, Week 12, Week 36, Week 52 · mean

Dulaglutide 1.5 mgn=612	Dulaglutide 3 mgn=616	Dulaglutide 4.5 mgn=614
11200(10900 to 11500)	22300(21800 to 22900)	33400(32700 to 34200)

The trial

How AWARD-11 was run

The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.

Dulaglutide 1.5 mg: Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
Dulaglutide 3 mg: Dulaglutide 3 mg administered SC once a week.
Dulaglutide 4.5 mg: Dulaglutide 4.5 mg administered SC once a week.

Who could join the trial

Inclusion Criteria: * Have type 2 diabetes mellitus (T2DM) for at least 6 months * Have been treated with stable metformin dose for at least 3 months * Have HbA1c ≥7.5% and ≤11.0% at study entry * Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Have type 1 diabetes mellitus * Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days) * Have been taking any other medicine for diabetes (other than metformin) during the last 3 months * Have used in the last 3 months (or plan to use) prescription weight loss medications * Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss * Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes) * Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial * Had chronic or acute pancreatitis any time prior to study entry * Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity * Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73m\^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in * Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 * Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator

Published papers

Papers from AWARD-11

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

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