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

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Glargine; Drug: LY3209590

Study type: Interventional

Funder types: Industry

Identifiers

NCT05596747

18221

I8H-MC-BDDC (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. Side effects and tolerability will be documented. Blood samples will be taken to assess how the body processes the study drug and the effect of the study drug on blood sugar levels. The study will last up to 18 weeks and may include 18 visits for each participant.

Enrollment: 31 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication.
• Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
• 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
• Native Chinese participant who has both parents and all 4 grandparents of Chinese origin.

Exclusion criteria

• Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes
• Have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening
• Are receiving insulin other than once daily basal insulin
• Have any active infectious or serious disease or major organs insufficiency
• Women who are pregnant or lactating

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

LY3209590

Experimental group

Description:

LY3209590 administered subcutaneously (SC).

Treatment:

Drug: LY3209590

Insulin glargine

Active Comparator group

Description:

Insulin glargine administered SC.

Treatment:

Drug: Insulin Glargine