Back to resultsA Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
LY3209590
Insulin Degludec
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Clinical Research Hospital Tokyo
- P-one clinic
- Yokohama Minoru Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LY3209590
Insulin Degludec
Arm Description
LY3209590 administered subcutaneously (SC).
Insulin degludec 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): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590
PK: AUC(0-168) of LY3209590
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in Fasting Plasma Glucose
Full Information
NCT ID
NCT04276428
First Posted
February 18, 2020
Last Updated
December 2, 2020
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04276428
Brief Title
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus
Official Title
A Multiple-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
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
November 28, 2020 (Actual)
Study Completion Date
November 28, 2020 (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
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
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 almost five months for each participant.
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
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3209590
Arm Type
Experimental
Arm Description
LY3209590 administered subcutaneously (SC).
Arm Title
Insulin Degludec
Arm Type
Active Comparator
Arm Description
Insulin degludec administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3209590
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec
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 85
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590
Description
PK: AUC(0-168) of LY3209590
Time Frame
Predose on Day 1 through Day 85
Title
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
Description
PD: Change from Baseline in Fasting Plasma Glucose
Time Frame
Day 1 through Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
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
Clinical Research Hospital Tokyo
City
Shinjuku-ku
State/Province
Jp-13
ZIP/Postal Code
162-0053
Country
Japan
Facility Name
P-one clinic
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0071
Country
Japan
Facility Name
Yokohama Minoru Clinic
City
Yokohama
ZIP/Postal Code
232-0064
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus
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