Status:
COMPLETED
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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%.
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2024
Estimated Enrollment :
928 Patients enrolled
Trial Details
Trial ID
NCT05362058
Start Date
June 3 2022
End Date
April 10 2024
Last Update
May 16 2025
Active Locations (113)
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1
Neighborhood Healthcare Institute of Health
Escondido, California, United States, 92025
2
Valley Research
Fresno, California, United States, 93720
3
NorCal Medical Research, Inc
Greenbrae, California, United States, 94904
4
Catalina Research Institute, LLC
Montclair, California, United States, 91763