A Study of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

• Status: Not yet recruiting
• Trial end date: 2024-05-14
• Target enrollment: 0
• Participant gender: All

Summary

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

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

Details

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

Criteria

Inclusion Criteria:

• Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin

• Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening

• Have HbA1c value of 6.5% - 10% inclusive, at screening

• Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)

• Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:

• once daily U100 or U200 of insulin degludec

• once daily U100 or U300 of insulin glargine

• once or twice daily U100 of insulin detemir, or

• once or twice daily human insulin NPH

• acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:

• dipeptidyl peptidase (DPP-4) IV inhibitors

• SGLT2 inhibitors

• metformin

• alphaglucosidase inhibitors or,

• Glucagon-Like Peptide-1 (GLP-1) receptor agonists

• Participants must be willing to stay on stable dose throughout the study

Exclusion Criteria:

• Have Type 1 diabetes mellitus

• Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)

• Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)

• Have active or untreated malignancy

• Are pregnant

• Have a significant weight gain or loss the past 3 months

• Have received anytime in the past 6 months, any of the following insulin therapies:

• prandial insulin

• insulin mixtures

• inhaled insulin

• U-500 insulin, or

• continuous subcutaneous insulin infusion therapy

• Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:

• acute myocardial infarctions

• cerebrovascular accident (stroke), or

• coronary bypass surgery

• Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening