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

Lilly

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin Degludec

Drug: LY3209590

Study type

Interventional

Funder types

Industry

Identifiers

NCT04276428

I8H-JE-BDCK (Other Identifier)

16983

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months for each participant.

Enrollment

28 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have type 2 diabetes mellitus (T2DM) for at least 1 year
Have received a stable daily dose of basal insulin at screening
Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
Have a body mass index greater than (>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening

Exclusion criteria

Have received a total daily dose of insulin >1.2 units per kilogram (U/kg) of body weight at screening
Have received insulins except for basal insulins
Have received sulfonylurea at more than half of the maximum approved dose level
Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy
Have had more than 1 episode of severe hypoglycemia within 6 months before entry