A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multiple-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276428
• Other study ID #: 16983
• Secondary ID: I8H-JE-BDCK
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2020
• Est. completion date: November 28, 2020

Study information

• Verified date: December 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 28, 2020
• Est. primary completion date: November 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3209590
Administered SC.
• Insulin Degludec
Administered SC.

Locations

Country	Name	City	State
Japan	P-one clinic	Hachioji	Tokyo
Japan	Clinical Research Hospital Tokyo	Shinjuku-ku	Jp-13
Japan	Yokohama Minoru Clinic	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Predose on Day 1 through Day 85
Secondary	Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose	PD: Change from Baseline in Fasting Plasma Glucose	Day 1 through Day 85