A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 27, 2019

Interventions

  • Drug: LY3209590
    • Administered SC
  • Drug: Placebo
    • Administered SC

Arms, Groups and Cohorts

  • Experimental: LY3209590
    • Insulin naïve participants with Type 2 Diabetes Mellitus received 5 mg and 10 mg LY3209590 administered subcutaneously (SC) in Cohort 1 and 2 respectively. Participants with T2DM received 20 mg LY3209590 administered subcutaneously in Cohort 3.
  • Active Comparator: Placebo
    • Participants from Cohort 1 and 2 received Placebo administered SC.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590
    • Time Frame: Baseline through Day 28
    • PK: Cmax of LY3209590
  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY3209590
    • Time Frame: Baseline through Day 28
    • PK: AUC of LY3209590
  • Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
    • Time Frame: Baseline through Day 15
    • PD: Change from Baseline in Fasting Plasma Glucose

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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), Study Director, Eli Lilly and Company

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.