A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

Completed · Phase 3

Conditions studied: Diabetes, Type 2 Diabetes

In brief

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.

Key facts

Study ID

NCT05362058

Run by

Eli Lilly and Company

People needed

928

Starts

2022-06-03

Expected to finish

2024-04-10

Last updated by the study team

2025-05-16

Who can join

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

You may qualify if…

• Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
• Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
• Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study
• These antihyperglycemic medications are accepted in the study
• dipeptidyl peptidase-4 (DPP-4) inhibitors
• sodium-glucose cotransporter 2 (SGLT2) inhibitors
• biguanides, such as metformin
• alpha-glucosidase inhibitors
• glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
• Sulfonylureas, or
• Thiazolidinediones.
• Are insulin naïve.
• Exceptions:
• short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes
• Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).

You may not qualify if…

• Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.
• Have a history of greater than (>) 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. Have had severe hypoglycemia episodes within 6 months prior to screening. Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
• Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
• Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
• Acute myocardial infarction
• Cerebrovascular accident (stroke), or
• Coronary bypass surgery.
• Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
• Have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.

Where it is running

• Valley Research — Fresno, California, United States
• NorCal Medical Research, Inc — Greenbrae, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Southern California Dermatology, Inc. — Santa Ana, California, United States
• New West Physicians Clinical Research — Golden, Colorado, United States
• New England Research Associates, LLC — Bridgeport, Connecticut, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• East Coast Institute for Research - Canton — Canton, Georgia, United States
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States
• Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Qualmedica Research, LLC — Evansville, Indiana, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Qualmedica Research — Bowling Green, Kentucky, United States
• MedStar Health Research Institute (MedStar Physician Based Research Network) — Hyattsville, Maryland, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• SKY Clinical Research Network Group-Quinn — Ridgeland, Mississippi, United States
• Clinvest Research LLC — Springfield, Missouri, United States
• Clarity Clinical Research — East Syracuse, New York, United States
• Great Lakes Medical Research, LLC — Westfield, New York, United States
• Monroe Biomedical Research — Monroe, North Carolina, United States
• Lucas Research, Inc — Morehead City, North Carolina, United States
• Intend Research, LLC — Norman, Oklahoma, United States
• Jefferson Clinical Research Institute (JCRI) — Philadelphia, Pennsylvania, United States
• Tribe Clinical Research, LLC — Greenville, South Carolina, United States
• Neighborhood Healthcare Institute of Health — Escondido, California, United States

Full record on ClinicalTrials.gov

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