Status:
COMPLETED
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
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 sampl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04276428
Start Date
February 28 2020
End Date
November 28 2020
Last Update
December 3 2020
Active Locations (3)
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1
Clinical Research Hospital Tokyo
Shinjuku-ku, Jp-13, Japan, 162-0053
2
P-one clinic
Hachiōji, Tokyo, Japan, 192-0071
3
Yokohama Minoru Clinic
Yokohama, Japan, 232-0064