A Study of LY3209590 in Participants With Type 1 Diabetes

Completed · Phase 2

Conditions studied: Type 1 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 1 diabetes.

Key facts

Study ID

NCT04450407

Run by

Eli Lilly and Company

People needed

266

Starts

2020-07-06

Expected to finish

2021-10-01

Last updated by the study team

2022-10-27

Who can join

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

You may qualify if…

• Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year
• Participants must have been using multiple daily injections without interruption for at least 3 months
• Participants must have HbA1c values of 5.6% to 9.5%, inclusive
• Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)

You may not qualify if…

• Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening
• Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
• Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
• Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
• Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²
• Have active or untreated cancer
• Are receiving chronic (>14 days) systemic glucocorticoid therapy

Where it is running

• Valley Endocrine, Fresno — Fresno, California, United States
• Coastal Metabolic Research Centre — Ventura, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• Denver Endocrinology, Diabetes & Thyroid Center — Englewood, Colorado, United States
• East Coast Institute for Research at The Jones Center — Jacksonville, Florida, United States
• Sun Coast Clinical Research, Inc — New Port Richey, Florida, United States
• Bayside Clinical Research, LLC — New Port Richey, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• East Coast Institute for Research at The Jones Center — Macon, Georgia, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Diabetes and Metabolism Associates, APMC — Metairie, Louisiana, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• Palm Research Center Tenaya — Las Vegas, Nevada, United States
• Southern Nh Diabetes and Endocrinology — Nashua, New Hampshire, United States
• Suny Health Science Center at Syracuse — Syracuse, New York, United States
• Lucas Research, Inc. — Morehead City, North Carolina, United States
• PMG Research of Piedmont Healthcare — Statesville, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Intend Research, LLC — Norman, Oklahoma, United States
• Holston Medical Group — Bristol, Tennessee, United States
• Univ Diab & Endo Consult — Chattanooga, Tennessee, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States

Full record on ClinicalTrials.gov

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