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NCT Number: NCT05596747

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3209590

Drug

Administered SC.

insulin glargine

Drug

Administered SC.

Primary outcomes

  1. 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

    Time frame: 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

  2. Incidence and Severity of Hypoglycemia

    Time frame: Baseline up to Week 12

    Incidence and Severity of Hypoglycemia

Secondary outcomes

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

    Time frame: Baseline through Week 6

    PD: Change from Baseline in Fasting Plasma Glucose

  2. PD: Change from Baseline in 7-Point Glucose

    Time frame: Baseline through Week 6

    PD: Change from Baseline in 7-Point Glucose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2022
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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