A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.

Key facts

Study ID: NCT02973100
Run by: Eli Lilly and Company
People needed: 318
Starts: 2016-12-01
Expected to finish: 2017-08-14
Last updated by the study team: 2019-09-23

Who can join

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

You may qualify if…

Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
Have been treated with stable doses of metformin for at least 3 months
Have a body mass index (BMI) ≥25 kilograms per square meter

You may not qualify if…

Have type 1 diabetes (T1D)
Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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
Have had chronic or acute pancreatitis any time prior to study entry
Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation
Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry

Where it is running

Marin Endocrine Associates — Greenbrae, 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
Artemis Institute for Clinical Research — San Diego, California, United States
Encompass Clinical Research — Spring Valley Lake, California, United States
University Clinical Investigators, Inc. — Tustin, California, United States
Infosphere — Van Nuys, California, United States
Diablo Clinical Research — Walnut Creek, California, United States
Chase Medical Research, LLC — Waterbury, Connecticut, United States
Axes Medical Research, LLC — Cooper City, Florida, United States
Clinical Research of South Florida — Coral Gables, Florida, United States
East Coast Institute For Research — Jacksonville, Florida, United States
New Horizon Research Center — Miami, Florida, United States
Suncoast Research Group, LLC — Miami Lakes, Florida, United States
Palm Harbor Medical Associates — Palm Harbor, Florida, United States
In-Quest Medical Research, LLC - Norcross — Norcross, Georgia, United States
East West Medical Institute — Honolulu, Hawaii, United States
Elite Cilnical Trials LLLP — Blackfoot, Idaho, United States
Solaris Clinical Research — Meridian, Idaho, United States
HSHS Medical Group Diabetes Research — Springfield, Illinois, United States
American Health Network — Indianapolis, Indiana, United States
Iderc, P.L.C. — Des Moines, Iowa, United States
Cotton O'Neil Diabetes and Endocrinology Center — Topeka, Kansas, United States
Parexel Early Phase Unit at Glendale — Glendale, California, United States

Full record on ClinicalTrials.gov

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