Skip to main content
OpenTrials
Completed

NCT Number: NCT03603704

A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

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 about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.

Completed

Looking for future studies?

Notify Me

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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

P-one clinic, Hachiōji, Tokyo, 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 T2DM diagnosed at least 1 year ago
  • Have hemoglobin A1c (HbA1c) ≥7.0% and ≤10.0% with fasting plasma glucose (FPG) ≥126 milligrams per deciliter (mg/dL) or HbA1c ≥6.5% and <7.0% with FPG ≥144 mg/dL at screening
  • Have body weight ≥54 kilograms and a body mass index >18.5 and ≤40.0 kilograms per square meter at screening

Exclusion criteria

  • Have received a total daily dose of insulin >1.2 units per kilogram at screening
  • Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening
  • Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction
  • Have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study

Treatment and study plan

LY3209590

Drug

Administered SC

Placebo

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 28

    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): Maximum Observed Concentration (Cmax) of LY3209590

    Time frame: Baseline through Day 28

    PK: Cmax of LY3209590

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3209590

    Time frame: Baseline through Day 28

    PK: AUC of LY3209590

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

    Time frame: Baseline through Day 15

    PD: Change from Baseline in Fasting Plasma Glucose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
Nov 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.