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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03495102

Run by

Eli Lilly and Company

People needed

1842

Starts

2018-04-05

Expected to finish

2019-10-10

Last updated by the study team

2020-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Synexus/Central Arizona Medical Associates, PC — Mesa, Arizona, United States
• Central Phoenix Med Clinic LLC — Phoenix, Arizona, United States
• Arkansas Clinical Research — Little Rock, Arkansas, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Valley Research — Fresno, California, United States
• National Research Institute — Huntington Park, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• National Research Institute — Panorama City, California, United States
• Sierra Clinical Research — Roseville, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Care Access Research — Santa Clarita, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Oviedo Medical Research — Oviedo, Florida, United States
• Urban Family Practice Associates, PC — Marietta, Georgia, United States
• Synexus- Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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