A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

• Status: Active, not recruiting
• Trial end date: 2021-10-04
• 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening

• Participants must have a HbA1c value of 7.0% to 9.5%, inclusive

• Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

• Have type 1 diabetes mellitus or latent autoimmune diabetes

• Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening

• Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)

• Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease

• Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²

• Have active or untreated cancer

• Are receiving chronic (>14 days) systemic glucocorticoid therapy