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A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

LY3209590

Placebo

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

P-one clinic
Sumida Hospital
Hakata Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY3209590

Placebo

Arm Description

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.

Participants from Cohort 1 and 2 received Placebo administered SC.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590

PK: Cmax of LY3209590

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

PK: AUC of LY3209590

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

PD: Change from Baseline in Fasting Plasma Glucose

Full Information

NCT ID

NCT03603704

First Posted

July 18, 2018

Last Updated

November 13, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03603704

Brief Title

A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

Official Title

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

Interventional

2. Study Status

Record Verification Date

November 1, 2020

Overall Recruitment Status

Completed

Study Start Date

August 17, 2018 (Actual)

Primary Completion Date

May 27, 2019 (Actual)

Study Completion Date

May 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Cohort 3 is open-label.

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3209590

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Active Comparator

Arm Description

Participants from Cohort 1 and 2 received Placebo administered SC.

Intervention Type

Drug

Intervention Name(s)

LY3209590

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline through Day 28

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590

Description

PK: Cmax of LY3209590

Time Frame

Baseline through Day 28

Title

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

Description

PK: AUC of LY3209590

Time Frame

Baseline through Day 28

Title

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

Description

PD: Change from Baseline in Fasting Plasma Glucose

Time Frame

Baseline through Day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

P-one clinic

City

Hachioji

State/Province

Tokyo

ZIP/Postal Code

192-0071

Country

Japan

Facility Name

Sumida Hospital

City

Sumida-ku

State/Province

Tokyo

ZIP/Postal Code

130-0004

Country

Japan

Facility Name

Hakata Clinic

City

Fukuoka

ZIP/Postal Code

812-0025

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

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A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

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