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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: LY3209590; Drug: Insulin Glargine

• Registration Number: NCT05596747
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Study Start: 2022-11-30
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3209590	LY3209590	LY3209590 administered subcutaneously (SC).
Insulin glargine	Insulin Glargine	Insulin glargine administered SC.

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Hypoglycemia	Baseline up to Week 12	Incidence and Severity of Hypoglycemia
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	Baseline up to Week 12	Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose	Baseline through Week 6	PD: Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in 7-Point Glucose	Baseline through Week 6	PD: Change from Baseline in 7-Point Glucose

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China