A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes

Lilly

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: LY3209590

Study type

Interventional

Funder types

Industry

Identifiers

NCT06169982

I8H-MC-BDDG (Other Identifier)

18811

2023-508008-39-00 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 days.

Enrollment

56 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants with Type 2 Diabetes (T2DM).
Participants who are insulin naive or receiving basal insulin [NPH (neutral protamine Hagedorn) once or twice daily, once-daily insulin glargine U100 or U300, once-daily insulin degludec, or insulin detemir once or twice daily] for fewer than 5 years prior to screening.
Have glycated hemoglobin (HbA1c) of ≥7.0 percent (%) to ≤9.5%, HbA1c of ≥6.5% to ≤9.5% for participants on treatment with sulfonylureas and/or Sodium-Glucose Transport Protein 2 inhibitors who require washout.
Have a body mass index between 27 and 40 kilograms per meter square.
Male or female participants who are willing to comply with the contraception requirements consistent with local regulations.
Be willing to allow blood sample collection, reliable and to be available for the duration of the study as required for the study protocol.

Exclusion criteria

Have known or suspected allergic reactions to study drugs, related compounds, excipients, and devices used in the study.
Have a specific type of diabetes other than T2DM.
Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
Participants with a history of kidney complications.