A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

• Status: Not yet recruiting
• Trial end date: 2024-04-19
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to measure the safety and efficacy of LY3209590 compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

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

Details

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

Criteria

Inclusion Criteria:

• Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening

• Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening

• Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.

• Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Exclusion Criteria:

• Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes

• Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.

• Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.