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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-10-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3209590

LY3209590 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3209590

Intervention Type DRUG

Administered SC.

Insulin glargine

Insulin glargine administered SC.

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type DRUG

Administered SC.

Interventions

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LY3209590

Administered SC.

Intervention Type DRUG

Insulin Glargine

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No