A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus
NCT ID: NCT04276428
Last Updated: 2020-12-03
Study Results
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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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2020-02-28
2020-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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LY3209590
LY3209590 administered subcutaneously (SC).
LY3209590
Administered SC.
Insulin Degludec
Insulin degludec administered SC.
Insulin Degludec
Administered SC.
Interventions
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LY3209590
Administered SC.
Insulin Degludec
Administered SC.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
74 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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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Clinical Research Hospital Tokyo
Shinjuku-ku, Jp-13, Japan
P-one clinic
Hachiōji, Tokyo, Japan
Yokohama Minoru Clinic
Yokohama, , Japan
Countries
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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.
Other Identifiers
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I8H-JE-BDCK
Identifier Type: OTHER
Identifier Source: secondary_id
16983
Identifier Type: -
Identifier Source: org_study_id