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

Purpose

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. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.

Conditions

  • Diabetes
  • Type 2 Diabetes

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have diagnosis of T2D according to the World Health Organization Criteria - Have an HbA1c of 7.0% - 10% inclusive, at screening - Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study

Exclusion Criteria

  • Have a diagnosis of T1D, latent autoimmune diabetes, or 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 >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 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, ≥5%.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Insulin Efsitora Alfa 		Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.
  • Drug: Insulin Efsitora Alfa
    Administered SC
    Other names:
    • LY3209590 and Basal Insulin-FC
Active Comparator
Insulin Degludec 		Participants will receive insulin degludec SC once daily
  • Drug: Insulin Degludec
    Administered SC

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Study Contact