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NCT Number: NCT04276428

A Study of LY3209590 in Japanese 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 Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months 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

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Hospital Tokyo, Shinjuku-ku, Jp-13, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have type 2 diabetes mellitus (T2DM) for at least 1 year
  • 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
  • Have a body mass index greater than (>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening

Exclusion criteria

  • Have received a total daily dose of insulin >1.2 units per kilogram (U/kg) of body weight at screening
  • Have received insulins except for basal insulins
  • Have received sulfonylurea at more than half of the maximum approved dose level
  • Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy
  • Have had more than 1 episode of severe hypoglycemia within 6 months before entry

Treatment and study plan

LY3209590

Drug

Administered SC.

insulin degludec

Drug

Administered SC.

Primary outcomes

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

    Time frame: Baseline through Day 85

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590

    Time frame: Predose on Day 1 through Day 85

    PK: AUC(0-168) of LY3209590

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

    Time frame: Day 1 through Day 85

    PD: Change from Baseline in Fasting Plasma Glucose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Multiple-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Dec 3, 2020

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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