A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes (AWARD-11)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03495102

2017-003490-33 (EudraCT Number)

H9X-MC-GBGL (Other Identifier)

16877

Details and patient eligibility

About

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.

Enrollment: 1,842 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,842 participants in 3 patient groups

Dulaglutide 1.5 mg

Active Comparator group

Description:

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

Treatment:

Drug: Dulaglutide

Dulaglutide 3 mg

Experimental group

Description:

Dulaglutide 3 mg administered SC once a week.

Treatment:

Drug: Dulaglutide

Dulaglutide 4.5 mg

Experimental group

Description:

Dulaglutide 4.5 mg administered SC once a week.

Treatment:

Drug: Dulaglutide