Status:
COMPLETED
A Study of LY3209590 in Participants With Type 1 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT04450407
Start Date
July 6 2020
End Date
October 1 2021
Last Update
October 27 2022
Active Locations (54)
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1
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
2
Valley Endocrine, Fresno
Fresno, California, United States, 93720
3
Coastal Metabolic Research Centre
Ventura, California, United States, 93003
4
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045