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

• Status: Not yet recruiting
• Trial end date: 2024-04-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect and safety of 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin

Criteria

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 a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization 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%.