A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Completed · Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.

Key facts

Study ID

NCT03736785

Run by

Eli Lilly and Company

People needed

399

Starts

2018-11-15

Expected to finish

2020-02-18

Last updated by the study team

2021-03-08

Who can join

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

You may qualify if…

• Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):
• dipeptidyl peptidase-4 (DPP-4) inhibitors
• sodium-glucose cotransporter (SGLT-2) inhibitors
• biguanides
• alpha-glucosidase inhibitors
• sulfonlyureas
• HbA1c value of 6.5% to 10%, inclusive
• Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

You may not qualify if…

• Type 1 diabetes mellitus or latent autoimmune diabetes
• Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
• Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
• Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
• Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2
• Active or untreated malignancy
• Chronic (>14 days) systemic glucocorticoid therapy

Where it is running

• Central Research Associates, Inc. — Birmingham, Alabama, United States
• Arkansas Clinical Research — Little Rock, Arkansas, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States
• AMCR Institute INC — Escondido, California, United States
• Valley Endocrine, Fresno — Fresno, California, United States
• Marin Endocrine Associates — Greenbrae, California, United States
• National Research Institute — Huntington Park, California, United States
• First Valley Medical Group — Lancaster, California, United States
• National Research Institute — Los Angeles, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Metabolic Research Institute Inc. — West Palm Beach, Florida, United States
• East West Medical Institute — Honolulu, Hawaii, United States
• Elite Clinical Trials LLLP — Blackfoot, Idaho, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Iderc, P.L.C. — West Des Moines, Iowa, United States
• Cotton O'Neil Diabetes and Endocrinology Center — Topeka, Kansas, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• NECCR PrimaCare Research, LLC — Fall River, Massachusetts, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Southern New Hampshire Diabetes and Endocrinology — Nashua, New Hampshire, United States
• Metrolina Internal Medicine, P.A. — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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