A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: LY3209590; Drug: Placebo

• Registration Number: NCT03603704
• Lead Sponsor: Eli Lilly and Company

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 about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Study Start: 2018-08-17
• Primary Completion: 2019-05-27
• Study Completion: 2019-05-27
• Status Verified: 2020-11-01
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3209590	LY3209590	Insulin naïve participants with Type 2 Diabetes Mellitus received 5 mg and 10 mg LY3209590 administered subcutaneously (SC) in Cohort 1 and 2 respectively. Participants with T2DM received 20 mg LY3209590 administered subcutaneously in Cohort 3.
Placebo	Placebo	Participants from Cohort 1 and 2 received Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 28	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

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

Trial Locations

Locations (3)

Sumida Hospital; 🇯🇵 Sumida-ku, Tokyo, Japan

Hakata Clinic; 🇯🇵 Fukuoka, Japan

P-one clinic; 🇯🇵 Hachioji, Tokyo, Japan