A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2020-02-18
• 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.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):

• dipeptidyl peptidase-4 (DPP-4) inhibitors

• sodium-glucose cotransporter (SGLT-2) inhibitors

• biguanides

• alpha-glucosidase inhibitors

• sulfonlyureas

• HbA1c value of 6.5% to 10%, inclusive

• Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

Exclusion Criteria:

• Type 1 diabetes mellitus or latent autoimmune diabetes

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

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

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

• Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2

• Active or untreated malignancy

• Chronic (>14 days) systemic glucocorticoid therapy