A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections

Completed · Phase 3

Conditions studied: Type 2 Diabetes, Type 2 Diabetes Treated With Insulin

In brief

The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.

Key facts

Study ID: NCT05462756
Run by: Eli Lilly and Company
People needed: 730
Starts: 2022-08-11
Expected to finish: 2024-02-27
Last updated by the study team: 2025-04-27

Who can join

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

You may qualify if…

Have a diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
Are receiving ≥10 units of total basal insulin per day at screening.
Are receiving ≤2 units/kilogram/day of total daily insulin at screening
Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
once daily U-100 or U-200 insulin degludec
once daily U-100 or U-300 insulin glargine
once or twice daily U-100 insulin detemir or
once or twice daily human insulin Neutral Protamine Hagedorn
Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.
Insulin lispro-aabc
Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)
Insulin aspart (U-100)
Insulin glulisine (U-100), or
Regular insulin (U-100)
Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
dipeptidyl peptidase IV inhibitors
sodium-glucose co-transporter-2 inhibitors
biguanides (for example, metformin), or
glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
Have a body mass index ≤45 kilogram/square meter (kg/m²)

You may not qualify if…

Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).
Are currently receiving any of the following insulin therapies anytime in the past 90 days:
insulin mixtures
insulin human, inhalation powder, or
continuous subcutaneous insulin infusion therapy, or
regular insulin U-500
Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
Have hypoglycemia unawareness in the opinion of the investigator
Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening

Where it is running

Tampa Bay Medical Research — Clearwater, Florida, United States
Panax Clinical Research — Miami Lakes, Florida, United States
Encore Medical Research - Weston — Weston, Florida, United States
Elite Clinical Trials — Blackfoot, Idaho, United States
Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
MedStar Good Samaritan Hospital — Baltimore, Maryland, United States
NECCR PrimaCare Research — Fall River, Massachusetts, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States
Palm Research Center Tenaya — Las Vegas, Nevada, United States
Palm Research Center Sunset — Las Vegas, Nevada, United States
Research Foundation of SUNY - University of Buffalo — Buffalo, New York, United States
Remington Davis Clinical Research — Columbus, Ohio, United States
Aventiv Research — Dublin, Ohio, United States
Heritage Valley Multispecialty Group, Inc — Beaver, Pennsylvania, United States
Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
Texas Diabetes & Endocrinology, P.A. — Austin, Texas, United States
Texas Diabetes & Endocrinology, P.A. — Austin, Texas, United States
North Texas Endocrine Center — Dallas, Texas, United States
Biopharma Informatic, LLC — Houston, Texas, United States
Research Institute of Dallas — Plano, Texas, United States
Consano Clinical Research, LLC — Shavano Park, Texas, United States
Chrysalis Clinical Research — St. George, Utah, United States
Rainier Clinical Research Center — Renton, Washington, United States
CEDIC — CABA, Buenos Aires, Argentina
CMR of Greater New Haven, LLC — Hamden, Connecticut, United States

Full record on ClinicalTrials.gov

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