A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Single Ascending 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: NCT03603704
• Other study ID #: 16552
• Secondary ID: I8H-JE-BDCF
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2018
• Est. completion date: May 27, 2019

Study information

• Verified date: November 1, 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 about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Have T2DM diagnosed at least 1 year ago

• Have hemoglobin A1c (HbA1c) =7.0% and =10.0% with fasting plasma glucose (FPG) =126 milligrams per deciliter (mg/dL) or HbA1c =6.5% and <7.0% with FPG =144 mg/dL at screening

• Have body weight =54 kilograms and a body mass index >18.5 and =40.0 kilograms per square meter at screening

Exclusion Criteria:

• Have received a total daily dose of insulin >1.2 units per kilogram at screening

• Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening

• Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction

• Have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3209590
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Japan	Hakata Clinic	Fukuoka
Japan	P-one clinic	Hachioji	Tokyo
Japan	Sumida Hospital	Sumida-ku	Tokyo

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 28
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590	PK: Cmax of LY3209590	Baseline through Day 28
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3209590	PK: AUC of LY3209590	Baseline through Day 28
Secondary	Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose	PD: Change from Baseline in Fasting Plasma Glucose	Baseline through Day 15