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A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

NCT ID: NCT03603704

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-17

Study Completion Date

2019-05-27

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Cohort 3 is open-label.

Study Groups

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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.

Group Type EXPERIMENTAL

LY3209590

Intervention Type DRUG

Administered SC

Placebo

Participants from Cohort 1 and 2 received Placebo administered SC.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3209590

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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P-one clinic

Hachiōji, Tokyo, Japan

Site Status

Sumida Hospital

Sumida-ku, Tokyo, Japan

Site Status

Hakata Clinic

Fukuoka, , Japan

Site Status

Countries

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Japan

References

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Nasu R, Oura T, Ohwaki K, Imori M, Furihata K. Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes. Diabetes Ther. 2025 Mar;16(3):513-526. doi: 10.1007/s13300-025-01695-x. Epub 2025 Feb 10.

Reference Type DERIVED
PMID: 39928225 (View on PubMed)

Other Identifiers

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I8H-JE-BDCF

Identifier Type: OTHER

Identifier Source: secondary_id

16552

Identifier Type: -

Identifier Source: org_study_id