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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05596747
• Other study ID #: 18221
• Secondary ID: I8H-MC-BDDC
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2022
• Est. completion date: October 10, 2023

Study information

• Verified date: December 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3209590
Administered SC.
• Insulin Glargine
Administered SC.

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline up to Week 12
Primary	Incidence and Severity of Hypoglycemia	Incidence and Severity of Hypoglycemia	Baseline up to Week 12
Secondary	Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose	PD: Change from Baseline in Fasting Plasma Glucose	Baseline through Week 6
Secondary	PD: Change from Baseline in 7-Point Glucose	PD: Change from Baseline in 7-Point Glucose	Baseline through Week 6