A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections
The reason for this study is to evaluate if the once-weekly study drug LY3209590 is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.
• Have a diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
• Are receiving ≥10 units of total basal insulin per day at screening.
• Are receiving ≤2 units/kilogram/day of total daily insulin at screening
• Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
• Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
• once daily U-100 or U-200 insulin degludec
• once daily U-100 or U-300 insulin glargine
• once or twice daily U-100 insulin detemir or
• once or twice daily human insulin Neutral Protamine Hagedorn
• Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.
• Insulin lispro-aabc
• Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)
• Insulin aspart (U-100)
• Insulin glulisine (U-100), or
• Regular insulin (U-100)
• Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
• dipeptidyl peptidase IV inhibitors
• sodium-glucose co-transporter-2 inhibitors
• biguanides (for example, metformin), or
• glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
• Have a body mass index ≤45 kilogram/square meter (kg/m²)