NCT04276428

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 almost five months for each participant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2020

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

February 18, 2020

Last Update Submit

December 2, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

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

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

    Baseline through Day 85

Secondary Outcomes (2)

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

    Predose on Day 1 through Day 85

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

    Day 1 through Day 85

Study Arms (2)

LY3209590

EXPERIMENTAL

LY3209590 administered subcutaneously (SC).

Drug: LY3209590

Insulin Degludec

ACTIVE COMPARATOR

Insulin degludec administered SC.

Drug: Insulin Degludec

Interventions

LY3209590DRUG

Administered SC.

LY3209590
Insulin DegludecDRUG

Administered SC.

Insulin Degludec

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Research Hospital Tokyo

Shinjuku-ku, Jp-13, 162-0053, Japan

Location

P-one clinic

Hachiōji, Tokyo, 192-0071, Japan

Location

Yokohama Minoru Clinic

Yokohama, 232-0064, Japan

Location

Related Publications (1)

  • 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.

    PMID: 39928225DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 19, 2020

Study Start

February 28, 2020

Primary Completion

November 28, 2020

Study Completion

November 28, 2020

Last Updated

December 3, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(3)