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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Active

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

LY3209590

Insulin Glargine

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY3209590

Insulin glargine

Arm Description

LY3209590 administered subcutaneously (SC).

Insulin glargine administered SC.

Outcomes

Primary Outcome Measures

Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration

Incidence and Severity of Hypoglycemia

Secondary Outcome Measures

Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose

PD: Change from Baseline in Fasting Plasma Glucose

PD: Change from Baseline in 7-Point Glucose

Full Information

NCT ID

NCT05596747

First Posted

October 25, 2022

Last Updated

September 5, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT05596747

Brief Title

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

Official Title

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 30, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LY3209590

Arm Type

Experimental

Arm Description

LY3209590 administered subcutaneously (SC).

Arm Title

Insulin glargine

Arm Type

Active Comparator

Arm Description

Insulin glargine administered SC.

Intervention Type

Drug

Intervention Name(s)

LY3209590

Intervention Description

Administered SC.

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine

Intervention Description

Administered SC.

Primary Outcome Measure Information:

Title

Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Description

Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration

Time Frame

Baseline up to Week 12

Title

Incidence and Severity of Hypoglycemia

Description

Incidence and Severity of Hypoglycemia

Time Frame

Baseline up to Week 12

Secondary Outcome Measure Information:

Title

Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose

Description

PD: Change from Baseline in Fasting Plasma Glucose

Time Frame

Baseline through Week 6

Title

PD: Change from Baseline in 7-Point Glucose

Description

PD: Change from Baseline in 7-Point Glucose

Time Frame

Baseline through Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Tianjin Medical University General Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300052

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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