Status:
COMPLETED
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. Th...
Eligibility Criteria
Inclusion
- Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
- Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
- Have HbA1c value of 6.5% - 10% inclusive, at screening
- Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
- Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
- once daily U100 or U200 of insulin degludec
- once daily U100 or U300 of insulin glargine
- once or twice daily U100 of insulin detemir, or
- once or twice daily human insulin NPH
- acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
- dipeptidyl peptidase (DPP-4) IV inhibitors
- SGLT2 inhibitors
- metformin
- alphaglucosidase inhibitors or,
- Glucagon-Like Peptide-1 (GLP-1) receptor agonists
- Participants must be willing to stay on stable dose throughout the study
Exclusion
- Have Type 1 diabetes mellitus
- Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
- Estimated glomerular filtration rate (eGFR) \<20 milliliters/minute/1.73 square meter (m²)
- Have active or untreated malignancy
- Are pregnant
- Have a significant weight gain or loss the past 3 months
- Have received anytime in the past 6 months, any of the following insulin therapies:
- prandial insulin
- insulin mixtures
- inhaled insulin
- U-500 insulin, or
- continuous subcutaneous insulin infusion therapy
- Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
- acute myocardial infarctions
- cerebrovascular accident (stroke), or
- coronary bypass surgery
- Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
986 Patients enrolled
Trial Details
Trial ID
NCT05275400
Start Date
March 8 2022
End Date
May 15 2024
Last Update
June 3 2025
Active Locations (127)
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1
Medical Investigations
Little Rock, Arkansas, United States, 72211
2
John Muir Physician Network Research Center
Concord, California, United States, 94520
3
AMCR Institute
Escondido, California, United States, 92025
4
National Research Institute - Huntington Park
Huntington Park, California, United States, 90255