The trial is taking place at:

Chase Medical Research, LLC | Waterbury, MA

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A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

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Status and phase

Active, not recruiting
Phase 3


Type 2 Diabetes


Drug: Insulin Efsitora Alfa
Drug: Insulin Degludec

Study type


Funder types



2021-002569-16 (EudraCT Number)
I8H-MC-BDCU (Other Identifier)

Details and patient eligibility


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. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.


986 patients




18+ years old


No Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

986 participants in 2 patient groups

Insulin Efsitora Alfa
Experimental group
Participants will be given insulin efsitora alfa subcutaneously (SC).
Drug: Insulin Efsitora Alfa
Insulin Degludec
Active Comparator group
Participants with be given insulin degludec SC.
Drug: Insulin Degludec

Trial contacts and locations



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