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

NCT05596747 | Completed Phase 1

• 2 other identifiers: 18221I8H-MC-BDDC
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

• Incidence and Severity of Hypoglycemia

  Incidence and Severity of Hypoglycemia

  Baseline up to Week 12

Secondary Outcomes (2)

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

  Baseline through Week 6

• PD: Change from Baseline in 7-Point Glucose

  Baseline through Week 6

Study Arms (2)

LY3209590

EXPERIMENTAL

LY3209590 administered subcutaneously (SC).

Drug: LY3209590

Insulin glargine

ACTIVE COMPARATOR

Insulin glargine administered SC.

Drug: Insulin Glargine

Interventions

LY3209590 DRUG

Administered SC.

LY3209590

Insulin Glargine DRUG

Administered SC.

Insulin glargine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 27, 2022
• Study Start: November 30, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)